ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
ALTTO
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
3 other identifiers
interventional
8,381
41 countries
912
Brief Summary
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2007
Longer than P75 for phase_3
912 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
Study Start
First participant enrolled
May 16, 2007
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2013
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedMarch 21, 2025
March 1, 2025
6.6 years
June 20, 2007
July 30, 2014
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS) at the Primary Analysis
Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence. DFS was estimated using the Kaplan Meier method. The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
Secondary Outcomes (7)
Disease-Free Survival (DFS) at the 10-Year Follow-Up
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years
Overall Survival (OS) at the Primary Analysis
From randomization until death due to any cause (median follow-up of 4.5 years)
Overall Survival (OS) at the 10-Year Follow-Up
From randomization until death due to any cause, assessed up to approximately 10 years
Analysis of Time to Recurrence (TTR)
From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
Analysis of Time to Distant Recurrence (TTDR)
From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years
- +2 more secondary outcomes
Study Arms (4)
Lapatinib plus Trastuzumab
EXPERIMENTALDesign 1: Oral lapatinib 1000 mg daily concurrent with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg loading dose followed by 2mg/kg IV weekly) concurrent with oral lapatinib 750 mg daily and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles (12 weeks). After completion of chemotherapy, the dose of lapatinib will be increased to 1000mg daily concurrently with trastuzumab every 3 weeks (6mg/kg without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concurrently with oral lapatinib 750mg plus weekly trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV. After the completion of chemotherapy, trastuzumab will be administered every 3 weeks (6mg/kg without loading dose) concurrent with lapatinib 1000mg daily for an additional 40 weeks (52 weeks total).
Trastuzumab followed by Lapatinib
EXPERIMENTALDesign 1: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks administered concomitantly and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles; followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) followed by a 6 week treatment-free interval followed by oral lapatinib 1500 mg daily for 28 weeks (52 weeks total).
Lapatinib
EXPERIMENTALDesign 1: Lapatinib 1500mg oral daily for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, oral lapatinib administered at 1500mg daily for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, the dose of lapatinib will be increased to 1500mg oral daily for an additional 40 weeks (52 weeks total).
Trastuzumab
ACTIVE COMPARATORDesign 1: Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab administered every 3 weeks (6mg/kg IV without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab (6mg/kg without loading dose) every 3 weeks for an additional 40 weeks (52 weeks total).
Interventions
Small molecule inhibitor
Eligibility Criteria
You may qualify if:
- Patients \>= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF \>= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =\< 1, were included.
- For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.
- Approved, signed written informed consent obtained prior to any study specific screening procedures.
You may not qualify if:
- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.
- Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
- Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.
- Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa)
- (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;
- Serious cardiac illness or medical conditions.
- Any of the following abnormal laboratory tests immediately prior to randomization:
- Serum total bilirubin \>1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\<2 x ULN) was allowed;
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 x ULN;
- Alkaline phosphatase (ALP) \>2.5 x ULN;
- Serum creatinine \>2.0 x ULN;
- Total white blood cell count (WBC) \<2.5 x 10\^9/L;
- Absolute neutrophil count \<1.5 x 10\^9/L;
- Platelets \<100 x 10\^9/L.
- Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- North Central Cancer Treatment Groupcollaborator
- National Cancer Institute (NCI)collaborator
- Breast International Groupcollaborator
- Canadian Cancer Trials Groupcollaborator
Study Sites (924)
Novartis Investigative Site
Mobile, Alabama, 36608, United States
Novartis Investigative Site
Anchorage, Alaska, 99508, United States
Novartis Investigative Site
Tucson, Arizona, 85715, United States
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Jonesboro, Arkansas, 72401, United States
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Duarte, California, 91010, United States
Novartis Investigative Site
Fairfield, California, 94533, United States
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La Jolla, California, 92093-0987, United States
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La Jolla, California, 92093, United States
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Loma Linda, California, 92534, United States
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Martinez, California, 94553-3156, United States
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Marysville, California, 95901, United States
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Mountain View, California, 94040, United States
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Oakland, California, 94609, United States
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Pleasanton, California, 94588, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94110, United States
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Aurora, Colorado, 80012, United States
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Boulder, Colorado, 80301, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80210, United States
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Denver, Colorado, 80218, United States
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Denver, Colorado, 80220, United States
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Fort Collins, Colorado, 80524, United States
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Fort Collins, Colorado, 80528, United States
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Thornton, Colorado, 80229, United States
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Wheat Ridge, Colorado, 80033, United States
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Hartford, Connecticut, 06105, United States
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New Haven, Connecticut, 06520, United States
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Dover, Delaware, 19901, United States
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Washington D.C., District of Columbia, 20007, United States
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Washington D.C., District of Columbia, 20307, United States
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Boca Raton, Florida, 33486, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Myers, Florida, 33916, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32224, United States
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Lakeland, Florida, 33805, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32803, United States
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Orlando, Florida, 32806, United States
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Weston, Florida, 33331, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30912, United States
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Columbus, Georgia, 31904, United States
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Decatur, Georgia, 30033, United States
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Savannah, Georgia, 31405, United States
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Honolulu, Hawaii, 96813, United States
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Honolulu, Hawaii, 96859, United States
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Lihue, Hawaii, 96766, United States
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Boise, Idaho, 83706, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60611, United States
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Evanston, Illinois, 60201, United States
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Harvey, Illinois, 60426, United States
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Kankakee, Illinois, 60901, United States
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Maywood, Illinois, 60153, United States
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Mount Vernon, Illinois, 62864, United States
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Oak Lawn, Illinois, 60453-2699, United States
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Ottawa, Illinois, 61350, United States
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Pekin, Illinois, 61554, United States
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Peoria, Illinois, 61615, United States
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Peru, Illinois, 61354, United States
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Princeton, Illinois, 61356, United States
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Rockford, Illinois, 61104, United States
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Rockford, Illinois, 61114, United States
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Skokie, Illinois, 60077, United States
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Springfield, Illinois, 62781-0001, United States
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Urbana, Illinois, 61801, United States
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Beech Grove, Indiana, 46107, United States
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Fort Wayne, Indiana, 46815, United States
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Indianapolis, Indiana, 46202, United States
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Kokomo, Indiana, 46904, United States
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Mishawaka, Indiana, 46545, United States
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Muncie, Indiana, 47303, United States
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South Bend, Indiana, 46601, United States
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South Bend, Indiana, 46617, United States
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Ames, Iowa, 50010, United States
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Bettendorf, Iowa, 52722, United States
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Cedar Rapids, Iowa, 52402, United States
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Des Moines, Iowa, 50309, United States
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Des Moines, Iowa, 50314, United States
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Mason City, Iowa, United States
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Sioux City, Iowa, 51101-1733, United States
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Waterloo, Iowa, 50702, United States
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Chanute, Kansas, 66720, United States
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El Dorado, Kansas, 67042, United States
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Independence, Kansas, 67301, United States
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Lawrence, Kansas, 66044, United States
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Prairie Village, Kansas, 66208, United States
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Pratt, Kansas, 67124, United States
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Topeka, Kansas, 66604, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40292, United States
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Baton Rouge, Louisiana, 70809, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70121, United States
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Portland, Maine, 04101, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287-8936, United States
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Bethesda, Maryland, 20889-5600, United States
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Frederick, Maryland, 21701, United States
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Silver Spring, Maryland, 20910, United States
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Towson, Maryland, 21204, United States
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Westminster, Maryland, 21157, United States
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Boston, Massachusetts, 02135, United States
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Hyannis, Massachusetts, 02601, United States
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Peabody, Massachusetts, 01960, United States
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Adrian, Michigan, 49221, United States
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Ann Arbor, Michigan, 48106-0995, United States
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Dearborn, Michigan, 48123, United States
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Detroit, Michigan, 48202, United States
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Flint, Michigan, 48532, United States
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Iron Mountain, Michigan, 49801, United States
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Kalamazoo, Michigan, 49007, United States
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Pontiac, Michigan, 48341-2985, United States
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Saginaw, Michigan, 48601, United States
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Saint Joseph, Michigan, 49085, United States
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Southfield, Michigan, 48075, United States
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Albert Lea, Minnesota, 56007, United States
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Duluth, Minnesota, 55805, United States
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Edina, Minnesota, 55435, United States
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Mankato, Minnesota, 56002, United States
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Maplewood, Minnesota, 55109, United States
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Minneapolis, Minnesota, 55407-3799, United States
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Minneapolis, Minnesota, 55415, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Louis Park, Minnesota, 55416, United States
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Saint Paul, Minnesota, 55101, United States
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Saint Paul, Minnesota, 55102, United States
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Shakopee, Minnesota, 55379, United States
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Waconia, Minnesota, 55387, United States
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Willmar, Minnesota, 56201, United States
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Pascagoula, Mississippi, 39581, United States
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Kansas City, Missouri, 64131, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63110, United States
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Billings, Montana, 59101, United States
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Bozeman, Montana, 59715, United States
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Great Falls, Montana, 59405, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68106, United States
Novartis Investigative Site
Omaha, Nebraska, 68114, United States
Novartis Investigative Site
Omaha, Nebraska, 68122, United States
Novartis Investigative Site
Omaha, Nebraska, 68124, United States
Novartis Investigative Site
Omaha, Nebraska, 68131, United States
Novartis Investigative Site
Omaha, Nebraska, 68198, United States
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Las Vegas, Nevada, 89169, United States
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Concord, New Hampshire, 03301, United States
Novartis Investigative Site
Hooksett, New Hampshire, 03106, United States
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Laconia, New Hampshire, 03246, United States
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Lebanon, New Hampshire, 03756, United States
Novartis Investigative Site
Hackensack, New Jersey, 07601, United States
Novartis Investigative Site
Livingston, New Jersey, 07039, United States
Novartis Investigative Site
New Brunswick, New Jersey, 08901, United States
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Princeton, New Jersey, 24740, United States
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Somerville, New Jersey, 08876, United States
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Sparta, New Jersey, 07871, United States
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Vineland, New Jersey, 08360, United States
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Albuquerque, New Mexico, 87106, United States
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Albuquerque, New Mexico, 87110, United States
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Las Cruces, New Mexico, 88011, United States
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Buffalo, New York, 14263, United States
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Cooperstown, New York, 13326, United States
Novartis Investigative Site
East Syracuse, New York, 13057, United States
Novartis Investigative Site
Manhasset, New York, 11030, United States
Novartis Investigative Site
New York, New York, 10003, United States
Novartis Investigative Site
New York, New York, 10011, United States
Novartis Investigative Site
New York, New York, 10016, United States
Novartis Investigative Site
New York, New York, 10032, United States
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Rochester, New York, 14642, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10467-2490, United States
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Chapel Hill, North Carolina, 27599, United States
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Hendersonville, North Carolina, 28791, United States
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Kinston, North Carolina, 28501, United States
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Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Washington, North Carolina, 27889, United States
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Winston-Salem, North Carolina, 27157, United States
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Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58122, United States
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Minot, North Dakota, 58701, United States
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Bowling Green, Ohio, 43402, United States
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Canton, Ohio, 44710, United States
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Chillicothe, Ohio, 54601, United States
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Cincinnati, Ohio, 45242, United States
Novartis Investigative Site
Clyde, Ohio, 43410, United States
Novartis Investigative Site
Columbus, Ohio, 43210, United States
Novartis Investigative Site
Columbus, Ohio, 43214, United States
Novartis Investigative Site
Columbus, Ohio, 43215, United States
Novartis Investigative Site
Columbus, Ohio, 43222, United States
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Dayton, Ohio, 45415, United States
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Franklin, Ohio, 45005-1066, United States
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Greenville, Ohio, 45331, United States
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Kettering, Ohio, 45429, United States
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Maumee, Ohio, 43623, United States
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Sandusky, Ohio, 44870, United States
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Sylvania, Ohio, 43560, United States
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Toledo, Ohio, 43623, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97210, United States
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Abington, Pennsylvania, 19001-3788, United States
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Bethlehem, Pennsylvania, 18015, United States
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Hershey, Pennsylvania, 17033, United States
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Kingston, Pennsylvania, 18704, United States
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Nashville, Pennsylvania, 37204, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pottstown, Pennsylvania, 19464, United States
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Sayre, Pennsylvania, 18840, United States
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West Reading, Pennsylvania, 19611, United States
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Charleston, South Carolina, 29406, United States
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Greenville, South Carolina, 29605, United States
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Rapid City, South Dakota, 57701, United States
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Chattanooga, Tennessee, 37403, United States
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Chattanooga, Tennessee, 37404, United States
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Jackson, Tennessee, 38301, United States
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Knoxville, Tennessee, 37920, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37208, United States
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Nashville, Tennessee, 37232, United States
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Beaumont, Texas, 77702-1449, United States
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Bedford, Texas, 76022, United States
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Fort Sam Houston, Texas, 78234, United States
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Fort Worth, Texas, 76104, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
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Lackland Air Force Base, Texas, 78236, United States
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Longview, Texas, 75601, United States
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McAllen, Texas, 78503-1298, United States
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Mesquite, Texas, 75150, United States
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Midland, Texas, 79701, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Salt Lake City, Utah, 84112, United States
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Hampton, Virginia, 23666, United States
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Richmond, Virginia, 23230, United States
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Roanoke, Virginia, 24014, United States
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Bellingham, Washington, 98225, United States
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Seattle, Washington, 98122, United States
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Seattle, Washington, 98133, United States
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Spokane, Washington, 99218, United States
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Tacoma, Washington, 98405, United States
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Charleston, West Virginia, 25304, United States
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Huntington, West Virginia, 25701, United States
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Appleton, Wisconsin, 53715, United States
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Chippewa Falls, Wisconsin, 54729, United States
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Eau Claire, Wisconsin, 54702, United States
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Green Bay, Wisconsin, 54301, United States
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La Crosse, Wisconsin, 54601, United States
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Madison, Wisconsin, 53717, United States
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Oshkosh, Wisconsin, 54904, United States
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Sturgeon Bay, Wisconsin, 54235, United States
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Berazategui, B1880BBF, Argentina
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Buenos Aires, C1125ABD, Argentina
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Buenos Aires, C1185AAT, Argentina
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Buenos Aires, C1417DTN, Argentina
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Mendoza, M5500AYB, Argentina
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Quilmes, 1878, Argentina
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Rosario, S2000KZE, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Santa Fe, 3000, Argentina
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Box Hill, Victoria, 3128, Australia
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Adelaide, 5000, Australia
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Bedford Park, 5042, Australia
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Bunbury, 6230, Australia
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Campbelltown, 2560, Australia
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Camperdown, 2050, Australia
Novartis Investigative Site
Coffs Harbour, 2450, Australia
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Concord, 2139, Australia
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East Bentleigh, 3165, Australia
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East Melbourne, 3002, Australia
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Heidelberg, 3084, Australia
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Hobart, 7000, Australia
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Lismore, 2480, Australia
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Liverpool, 2170, Australia
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Melbourne, 3002, Australia
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Murdoch, 6150, Australia
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Nambour, 4560, Australia
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Nedlands, 6009, Australia
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North Sydney, 2060, Australia
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Parkville, 3050, Australia
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Port Macquarie, 2444, Australia
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Randwick, 2031, Australia
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South Brisbane, 4101, Australia
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Subiaco, 6008, Australia
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Taree, 2430, Australia
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Tweed Heads, 2485, Australia
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Wagga Wagga, 2650, Australia
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Waratah, 2298, Australia
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Wendouree, 3355, Australia
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Westmead, 2145, Australia
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Woodville, 5011, Australia
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Woolloongabba, 4102, Australia
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Rankweil, 6830, Austria
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Salzburg, 5020, Austria
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Villach, 9500, Austria
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Bonheiden, 2820, Belgium
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Bruges, 8000, Belgium
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Brussels, 1000, Belgium
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Brussels, 1020, Belgium
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Brussels, 1050, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Haine-Saint-Paul, 7100, Belgium
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Hasselt, 3500, Belgium
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Huy, 4500, Belgium
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Jette, 1090, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Mons, 7000, Belgium
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Namur, 5000, Belgium
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Roeselare, 8800, Belgium
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Sint-Niklaas, 9100, Belgium
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Tournai, 7500, Belgium
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Turnhout, 2300, Belgium
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Verviers, 4800, Belgium
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Wilrijk, 2610, Belgium
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Yvoir, 5530, Belgium
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Jaú, São Paulo, 17210-120, Brazil
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Belo Horizonte, 30150-270, Brazil
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Porte Alegre, 90430-001, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 90430-090, Brazil
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Porto Alegre, 90560-030, Brazil
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Porto Alegre, 90610000, Brazil
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Rio de Janeiro, 20560-120, Brazil
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Salvador, 40050-410, Brazil
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Santo André, 09060-650, Brazil
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Shumen, 9700, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9010, Bulgaria
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Toronto, Ontario, M4N 3M5, Canada
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Charlottetown, C1A 8T5, Canada
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Kelowna, V1Y 5L3, Canada
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London, N6A 4L6, Canada
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Moncton, E1C 8X3, Canada
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Regina, S4T 7T1, Canada
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Sault Ste. Marie, P6A 2C4, Canada
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Sherbrooke, J1H 5N4, Canada
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St. Catharines, L2R 7C6, Canada
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Vancouver, V5Z 4E6, Canada
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Santiago, 7500921, Chile
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Santiago, 7650635, Chile
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Santiago, 8360160, Chile
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Santiago, 8380455, Chile
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Temuco, 481-0469, Chile
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Valdivia, 5090145, Chile
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Valparaíso, 2341131, Chile
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Viña del Mar, 254-0364, Chile
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Beijing, 100021, China
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Beijing, 100071, China
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Guangzhou, 510060, China
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Shanghai, 200032, China
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Tianjin, 300060, China
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Brno, 656 91, Czechia
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Chomutov, 43012, Czechia
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České Budějovice, 370 87, Czechia
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Jihlava, 586 01, Czechia
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Nový Jičín, 741 01, Czechia
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Pardubice, 532 03, Czechia
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Prague, 100 34, Czechia
Novartis Investigative Site
Prague, 128 08, Czechia
Novartis Investigative Site
Prague, 140 59, Czechia
Novartis Investigative Site
Prague, 150 08, Czechia
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Prague, 180 00, Czechia
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Ústí nad Labem, 40113, Czechia
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Aalborg, 9100, Denmark
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Arhus C, 8000, Denmark
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Esbjerg, 6700, Denmark
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Herlev, 2730, Denmark
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Hilleroed, 3400, Denmark
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Koebenhavn Oe, 2100, Denmark
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Næstved, 4700, Denmark
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Odense, 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Viborg, 8800, Denmark
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Angers, 49055, France
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Annecy, 74000, France
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Avignon, 84000, France
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Bayonne, 64100, France
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Béthune, 62400, France
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Brive-la-Gaillarde, 19100, France
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Bron, 69677, France
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Caen, 14076, France
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Clermont-Ferrand, 63000, France
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Coudekerque-Branche, 59210, France
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Dijon, 21079, France
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Draguignan, 83007, France
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Grenoble, 38028, France
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Hyères, 83400, France
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La Seyne-sur-Mer, 83500, France
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Le Mans, 72000, France
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Lille, 59000, France
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Lyon, 69008, France
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Lyon, 69337, France
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Marseille, 13273, France
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Marseille, 13285, France
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Marseille, 13385, France
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Metz, 57045, France
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Mont-de-Marsan, 40024, France
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Montbéliard, 25200, France
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Nancy, 54100, France
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Nice, 06189, France
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Nîmes, 30029, France
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Paris, 75248, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Paris, 75674, France
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Perin Sur Mer, 22190, France
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Perpignan, 66000, France
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Périgueux, 24004, France
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Reims, 51100, France
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Rouen, 76000, France
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Rouen, 76038, France
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Saint-Cloud, 92210, France
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Saint-Grégoire, 67085, France
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Saint-Herblain, 44805, France
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Saint-Jean, 31240, France
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Saint-Priest-en-Jarez, 42271, France
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Strasbourg, 67000, France
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Strasbourg, 67085, France
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Toulouse, 31077, France
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Toulouse, 31300, France
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Tours, 37044, France
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Valenciennes, 59322, France
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Vandœuvre-lès-Nancy, 54511, France
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Villejuif, 94805, France
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Ansbach, 91522, Germany
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Aschaffenburg, 63739, Germany
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Aschersleben, 06449, Germany
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Aurich, 26603, Germany
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Bad Oldesloe, 23843, Germany
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Bad Reichenhall, 83435, Germany
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Baden-Baden, 76532, Germany
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Bayreuth, 95445, Germany
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Bergisch Gladbach, 51465, Germany
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Berlin, 10117, Germany
Novartis Investigative Site
Berlin, 10317, Germany
Novartis Investigative Site
Berlin, 10367, Germany
Novartis Investigative Site
Berlin, 10967, Germany
Novartis Investigative Site
Berlin, 12559, Germany
Novartis Investigative Site
Berlin, 13125, Germany
Novartis Investigative Site
Berlin, 13589, Germany
Novartis Investigative Site
Berlin, 14169, Germany
Novartis Investigative Site
Berlin, 14197, Germany
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Bielefeld, 33604, Germany
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Bonn, 53113, Germany
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Bonn, 53127, Germany
Novartis Investigative Site
Bonn, 53129, Germany
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Böblingen, 71032, Germany
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Brandenburg, 14770, Germany
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Braunschweig, 38100, Germany
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Bremen, 28209, Germany
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Bremen, 28239, Germany
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Bremerhaven, 27574, Germany
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Chemnitz, 09116, Germany
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Coburg, 96450, Germany
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Cologne, 50677, Germany
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Cologne, 50935, Germany
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Cologne, 50937, Germany
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Cuxhaven, 27474, Germany
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Dachau, 85221, Germany
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Deggendorf, 94469, Germany
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Donauwörth, 86609, Germany
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Dresden, 01127, Germany
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Dresden, 01307, Germany
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Duisburg, 47166, Germany
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Düsseldorf, 40225, Germany
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Düsseldorf, 40325, Germany
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Eggenfelden, 84307, Germany
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Erfurt, 99085, Germany
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Erlangen, 91054, Germany
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Eschweiler, 52249, Germany
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Essen, 45122, Germany
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Essen, 45130, Germany
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Essen, 45136, Germany
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Esslingen am Neckar, 73730, Germany
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Flensburg, 24939, Germany
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Frankfurt, 60389, Germany
Novartis Investigative Site
Frankfurt, 60596, Germany
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Frankfurt, 65929, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Friedrichshafen, 88048, Germany
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Fürstenwalde, 15517, Germany
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Fürth, 90766, Germany
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Garmisch-Partenkirchen, 82467, Germany
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Georgsmarienhütte, 49124, Germany
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Gera, 07548, Germany
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Goslar, 38642, Germany
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Göppingen, 73035, Germany
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Göttingen, 37075, Germany
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Greifswald, 17487, Germany
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Gummersbach, 51643, Germany
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Güstrow, 18273, Germany
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Halle, 06110, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Hamburg, 20259, Germany
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Hamburg, 20357, Germany
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Hamburg, 22081, Germany
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Hamburg, 22359, Germany
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Hamburg, 22457, Germany
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Hamelin, 31785, Germany
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Hamm-Heessen, 59073, Germany
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Hanover, 30177, Germany
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Hanover, 30559, Germany
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Heide, 25746, Germany
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Heidelberg, 69115, Germany
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Heidelberg, 69120, Germany
Novartis Investigative Site
Herne, 44623, Germany
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Homburg, 66421, Germany
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Hoyerswerda, 02977, Germany
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Itzehoe, 25524, Germany
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Jena, 07743, Germany
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Karlsruhe, 76135, Germany
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Karlsruhe, 76199, Germany
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Kassel, 34117, Germany
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Kassel, 34125, Germany
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Kempten, 87439, Germany
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Kiel, 24103, Germany
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Kiel, 24105, Germany
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Konstanz, 78464, Germany
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Landshut, 84034, Germany
Novartis Investigative Site
Landshut, 84036, Germany
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Landstuhl, 66849, Germany
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Leer, 26789, Germany
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Leipzig, 04129, Germany
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Leipzig, 04277, Germany
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Leverkusen, 51375, Germany
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Limburg, 65549, Germany
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Loerrach, 79539, Germany
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Luckenwalde, 14943, Germany
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Ludwigsburg, 71640, Germany
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Ludwigsfelde, 14974, Germany
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Ludwigshafen, 67063, Germany
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Lübeck, 23538, Germany
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Magdeburg, 39130, Germany
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Mainz, 55131, Germany
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Mannheim, 68165, Germany
Novartis Investigative Site
Mannheim, 68167, Germany
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Marktredwitz, 95615, Germany
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Meiningen, 98617, Germany
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Memmingen, 87700, Germany
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Minden, 32429, Germany
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Mönchengladbach, 41061, Germany
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Mutlangen, 73557, Germany
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Mühlhausen, 99974, Germany
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München, 80335, Germany
Novartis Investigative Site
München, 80638, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
München, 81925, Germany
Novartis Investigative Site
Münster, 48149, Germany
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Neumünster, 24534, Germany
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Neunkirchen, 66539, Germany
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Nuremberg, 90491, Germany
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Offenbach, 63069, Germany
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Oldenburg, 26121, Germany
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Oldenburg, 26133, Germany
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Olpe, 57462, Germany
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Osnabrück, 49074, Germany
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Ostfildern, 73760, Germany
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Porta Westfalica, 32457, Germany
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Radebeul, 01445, Germany
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Ravensburg, 88212, Germany
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Rendsburg, 24768, Germany
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Reutlingen, 72764, Germany
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Rheinfelden, 79618, Germany
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Rodewisch, 08228, Germany
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Rosenheim, 83022, Germany
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Rostock, 18059, Germany
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Rotenburg (Wümme), 27356, Germany
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Saarbrücken, 66113, Germany
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Schkeuditz, 04435, Germany
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Schwäbisch Hall, 74523, Germany
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Sigmaringen, 72488, Germany
Novartis Investigative Site
Stade, 21680, Germany
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Stadthagen, 31655, Germany
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Stendal, 39576, Germany
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Stralsund, 18435, Germany
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Stuttgart, 70174, Germany
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Stuttgart, 70376, Germany
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Torgau, 04860, Germany
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Trier, 54290, Germany
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Troisdorf, 53840, Germany
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Tübingen, 72076, Germany
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Ulm, 89075, Germany
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Vechta, 49377, Germany
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Velbert, 42551, Germany
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Villingen-Schwenningen, 78050, Germany
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Weißenfels, 06667, Germany
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Wesel, 46485, Germany
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Westerstede, 26655, Germany
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Wiesbaden, 65189, Germany
Novartis Investigative Site
Wiesbaden, 65191, Germany
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Wiesbaden, 65199, Germany
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Witten, 58452, Germany
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Wuppertal, 42105, Germany
Novartis Investigative Site
Wuppertal, 42283, Germany
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Würselen, 52146, Germany
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Würzburg, 97080, Germany
Novartis Investigative Site
Zittau, 02763, Germany
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Zwickau, 08060, Germany
Novartis Investigative Site
Athens, 11522, Greece
Novartis Investigative Site
Athens, 11527, Greece
Novartis Investigative Site
Athens, 15123, Greece
Novartis Investigative Site
Athens, 18547, Greece
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Heraklion, 71110, Greece
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Pátrai, 26504, Greece
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Thessaloniki, 546 45, Greece
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Kowloon, Hong Kong
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Tuenmen, Hong Kong
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Budapest, 1032, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Győr, 9023, Hungary
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Szeged, 6720, Hungary
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Gūrgaon, 122002, India
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Hyderabad, 500082, India
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Kolkata, 700016, India
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Mumbai, 400012, India
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Nagpur, 440010, India
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New Delhi, 110029, India
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New Delhi, 110076, India
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Trivandrum, 695011, India
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Cork, Ireland
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Dublin, 24, Ireland
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Dublin, 7, Ireland
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Dublin, 8, Ireland
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Dublin, 9, Ireland
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Galway, Ireland
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Netanya, 52621, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Zrifin, 70300, Israel
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Asti, 14100, Italy
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Avellino, 83100, Italy
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Aviano, 33081, Italy
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Bergamo, 24127, Italy
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Biella, 13900, Italy
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Brescia, 25123, Italy
Novartis Investigative Site
Brescia, 25124, Italy
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Brindisi, 72100, Italy
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Candiolo, 10060, Italy
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Carpi, 41012, Italy
Novartis Investigative Site
Cosenza, 87100, Italy
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Cremona, 26100, Italy
Novartis Investigative Site
Fano, 61032, Italy
Novartis Investigative Site
Fermo, 63023, Italy
Novartis Investigative Site
Florence, 50134, Italy
Novartis Investigative Site
Genova, 16132, Italy
Novartis Investigative Site
Lecce, 73100, Italy
Novartis Investigative Site
Lecco, 23900, Italy
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Lido di Camaiore, 55043, Italy
Novartis Investigative Site
Livorno, 57123, Italy
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Mantova, 46100, Italy
Novartis Investigative Site
Meldola, 47014, Italy
Novartis Investigative Site
Milan, 20142, Italy
Novartis Investigative Site
Milan, 20162, Italy
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Monserrato, 09042, Italy
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Monza, 20052, Italy
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Pavia, 27100, Italy
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Poggibonsi, 53036, Italy
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Potenza, 85100, Italy
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Prato, 59100, Italy
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Ragusa, 97100, Italy
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Ravenna, 48100, Italy
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Rimini, 47900, Italy
Novartis Investigative Site
Rozzano, 20089, Italy
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San Fermo della Battaglia, 22020, Italy
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Saronno, 21047, Italy
Novartis Investigative Site
Sassari, 07100, Italy
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Trento, 38122, Italy
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Treviglio, 24027, Italy
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Udine, 33100, Italy
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Varese, 21100, Italy
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Viterbo, 01100, Italy
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Aichi, 464-8681, Japan
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Chiba, 277-8577, Japan
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Ehime, 791-0280, Japan
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Fukuoka, 811-1395, Japan
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Ibaraki, 305-8576, Japan
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Kanagawa, 259-1143, Japan
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Kyoto, 606-8507, Japan
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Osaka, 530-8480, Japan
Novartis Investigative Site
Osaka, 540-0006, Japan
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Saitama, 350-1298, Japan
Novartis Investigative Site
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Related Publications (7)
Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3.
PMID: 39613746DERIVEDNader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.
PMID: 36050448DERIVEDMoreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.
PMID: 33765513DERIVEDSonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.
PMID: 33152119DERIVEDEiger D, Ponde NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Lang I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.
PMID: 32203207DERIVEDHolmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.
PMID: 31240310DERIVEDMcCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7.
PMID: 24395109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
June 20, 2007
First Posted
June 22, 2007
Study Start
May 16, 2007
Primary Completion
December 6, 2013
Study Completion
July 1, 2021
Last Updated
March 21, 2025
Results First Posted
August 18, 2014
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com