Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

ClinicalTrials.gov Identifier: NCT02941926

Novartis Reference Number: CLEE011A2404

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.

Condition 
Breast Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
3255 participants
Start date 
Nov 30, 2016
Completion date 
May 08, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ribociclib
Ribociclib oral (3 weeks on/1 week off), 600 mg ribociclib QD
Drug
Letrozole
Oral once daily, 2.5 mg letrozole QD
Drug
Goserelin
Only for men and premenopausal women: administered as an injectable subcutaneous implant once every 28 days
Drug
Leuprolide
Only for men and premenopausal women: administered as an injectable intramuscular depot once every 28 days

Eligibility Criteria

Inclusion Criteria:

Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.

In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.

Postmenopausal status is defined either by:

I). Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range (NCCN Guidelines version 2.2017).

Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure menopausal status.

Premenopausal status is defined as either:

I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.

Perimenopausal status is define as neither premenopausal nor postmenopausal Note: Throughout this document, perimenopausal and premenopausal status is grouped together and referred as "Premenopausal"
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):

Absolute neutrophil count ≥ 1.5 × 10^9/L
Platelets ≥ 100 × 10^9/L
Hemoglobin ≥ 9.0 g/dL
Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
INR ≤1.5
Serum creatinine <1.5 mg/dl or creatinine clearance≥50 mL/min
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome

Patient must have a 12-lead ECG with ALL of the following parameters at screening:

QTcF interval at screening <450 msec (using Fridericia's correction)
Resting heart rate ≥ 50 bpm

Exclusion Criteria:

Patient who received any CDK4/6 inhibitor
Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted

Note:

Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until study entry.
Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.

Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease must be stopped at least 5 half-lives or 7 days, whichever is longer, before study inclusion.

Patient is concurrently using other anti-cancer therapy.

Study Locations

United States
Alaska Cancer Research and Education Center
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Anchorage, 99508
Alaska
United States
Ironwood Cancer and Research Centers
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Chandler, 85224
Arizona
United States
Arizona Oncology Associates
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Phoenix,
Arizona
United States
Arizona Oncology Associates Arizona Oncology Assoc. (2)
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Tucson, 85745
Arizona
United States
Highlands Oncology Group
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Fayetteville, 72703
Arkansas
United States
Beverly Hills Cancer Center
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Beverly Hills, 90211
California
United States
Pacific Shores Medical Group SC
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Long Beach, 90813
California
United States
USC Norris Cancer Center
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Los Angeles, 90033
California
United States
University of California Irvine UC Irvine (11)
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Orange, 92868
California
United States
Ventura County Hematology and Oncology
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Oxnard, 93030
California
United States
PCR Oncology
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Pismo Beach, 93449
California
United States
California Pacific Medical Center Onc Dept
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San Francisco, 94120-7999
California
United States
Centura Health Research Center Centura Health Research Center
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Denver, 80210
Colorado
United States
Poudre Valley Hospital Poudre Valley Health System
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Fort Collins, 80528
Colorado
United States
Valley View Hospital Cancer Center
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Glenwood Springs, 81601
Colorado
United States
Foundation for Sickle Cell Disease Research
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Hollywood, 33021
Florida
United States
Watson Clinic Center for Research 1730 Location
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Lakeland, 33805
Florida
United States
Mid Florida Hematology and Oncology Center
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Orange City, 32763
Florida
United States
Summit Cancer Care Summit Cancer Care (SC)
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Savannah, 31405
Georgia
United States
John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
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Thomasville, 31792
Georgia
United States
Saint Alphonsus Regional Medical Center
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Boise, 83706
Idaho
United States
Stroger Cook County Hospital Division of Hematology & Onc
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Chicago, 60612
Illinois
United States
Joliet Oncology-Hematology Associates Presence Cancer Center
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Joliet, 60435
Illinois
United States
Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
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Normal, 61761
Illinois
United States
Alpha Med Physician Group, LLC
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Tinley Park, 60487
Illinois
United States
Indiana University Health Goshen Center for Cancer SC
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Goshen, 46526
Indiana
United States
Northwest Oncology
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Munster, 46321
Indiana
United States
June E. Nylan Cancer Center
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Sioux City, 51101
Iowa
United States
University of Kansas Cancer Center University of Kansas Med Ctr 9
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Kansas City, 66160
Kansas
United States
Sarah Cannon at Overland Park Regional Medical Center
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Overland Park, 66209
Kansas
United States
John Ochsner Heart and Vascular Institute Clinical Trials
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New Orleans, 70121
Louisiana
United States
Mercy Oncology / Hematology Center SC
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Portand, 04102
Maine
United States
Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
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Baltimore, 21204-6831
Maryland
United States
Maryland Oncology Hematology, P.A. Columbia
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Rockville, 20850
Maryland
United States
Kaiser Permanente
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Rockville, 20879
Maryland
United States
Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
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Washington DC, 20037
Maryland
United States
Jackson Oncology Associates
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Jackson, 39202
Mississippi
United States
Nebraska Hematology-Oncology, P.C.
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Lincoln, 68506
Nebraska
United States
Nebraska Cancer Specialists Oncology Hematology West
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Omaha, 68154
Nebraska
United States
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
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Las Vegas, 89109
Nevada
United States
Trinitas Comprehensive Cancer Center
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Elizabeth, 07207
New Jersey
United States
Englewood Hospital and Medical Center
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Englewood, 07631
New Jersey
United States
The Valley Hospital / Luckow Pavillion
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Paramus, 07652
New Jersey
United States
Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
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Somerset, 08873
New Jersey
United States
New Mexico Cancer Care Alliance
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Albuquerque, 87106
New Mexico
United States
San Juan Oncology Associates
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Farmington, 87401
New Mexico
United States
Eastchester Center for Cancer Care
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Bronx, 10469
New York
United States
Clinical Research Alliance
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Lake Success, 11042
New York
United States
Oncology Speciialists of Charlotte
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Charlotte, 28207
North Carolina
United States
Aultman Hospital
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Canton, 44710
Ohio
United States
The Christ Hospital Cancer Center Research Program Linder Research Center
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Cincinnati, 45219
Ohio
United States
University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
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Cleveland, 44106
Ohio
United States
Cleveland Clinic Cleveland Clinic (5)
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Cleveland, 44195
Ohio
United States
Dayton Physicians
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Kettering, 45409
Ohio
United States
Oklahoma Cancer Specialists and Research Institute SC-2
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Tulsa, 74136
Oklahoma
United States
Oregon Health and Science University SC-5
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Portland, 97239
Oregon
United States
McLeod Center for Cancer Treatment and Research
-
Florence, 29506
South Carolina
United States
Carolina Blood and Cancer Care of South Carolina
-
Rock Hill, 29732
South Carolina
United States
Millennium Oncology Millennium Oncology - FL
-
Houston, 77090
Texas
United States
Cancer Therapy and Research Center UT Health Science Center
-
San Antonio, 78229
Texas
United States
Hope Cancer Center of East Texas
-
Tyler, 75701
Texas
United States
Virginia Oncology Associates
-
Norfolk, 23502
Virginia
United States
PeaceHealth St Joseph Medical Center
-
Bellingham, 98225
Washington
United States
Providence Regional Medical Centre of Everett
-
Everett, 98201
Washington
United States
Kadlec Clinic Hematology and Oncology
-
Kennewick, 99336
Washington
United States
Valley Medical Center Research Valley Medical Center
-
Renton, 98055
Washington
United States
Virginia Mason Medical Center-Oncology SC
-
Seattle, 98101
Washington
United States
Northwest Medical Specialties Dept.ofNW Med. Specialties
-
Tacoma, 98405
Washington
United States
Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
-
Milwaukee, 53211
Wisconsin
United States
Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
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Cheyenne, 82001
Wyoming
United States
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La Rioja, 5300
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Graz, 8036
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Rankweil, A-6830
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Sint Niklaas, 9100
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Antwerp, 2020
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Bonheiden, 2820
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Brugge, 8000
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Gabrovo, 5300
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Plovdiv, 4004
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Sofia, 1303
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Cambridge, N1R 3G2
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Hamilton, L8V 5C2
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Kitchener, N2G 1G3
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London, N6A 4G4
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Newmarket, L3Y 2P9
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North York, M2K1E1
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Oshawa, L1G 2B9
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Ottawa, KIH 7W9
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Sault Ste Marie, P6B 0A8
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Sudbury, P3E 5J1
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Toronto, M3M 0B2
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Toronto, M4N 3M5
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Toronto, M5B 1W8
Ontario
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Greenfield Park, J4V 2H1
Quebec
Canada
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Laval, H7M 3L9
Quebec
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Montreal, H3T 1E2
Quebec
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Montreal, H3T 1M5
Quebec
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Montreal, H4J 1C5
Quebec
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Sherbrooke, J1H 5N4
Quebec
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Regina, S4T 7T1
Saskatchewan
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Saskatoon, S7N 4H4
Saskatchewan
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Quebec, G1S 4L8
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Canada
Chile
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Santiago, 8420383
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Chile
Czechia
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Brno, 656 53
Czech Republic
Czechia
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Liberec, 46063
Czech Republic
Czechia
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Prague 8, 180 00
Czech Republic
Czechia
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Zlin, 762 75
Czech Republic
Czechia
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Hradec Kralove, 500 05
CZE
Czechia
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Olomouc, 775 20
CZE
Czechia
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Brno, 625 00
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Czechia
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Ceske Budejovice, 370 87
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Czechia
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Pardubice, 532 03
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Czechia
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Prague 5, 150 00
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Czechia
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Praha 10, 100 34
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Czechia
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Praha 4, 140 59
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Czechia
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Praha, 12808
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Czechia
Denmark
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Copenhagen, DK-2100
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Denmark
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Vejle, 7100
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Denmark
Finland
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Helsinki, 00029
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Finland
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Oulu, FIN-90220
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Finland
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Tampere, FIN-33521
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Finland
France
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Nice Cedex 2, 06189
Alpes Maritimes
France
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Dijon Cedex, 21034
Cote D Or
France
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Limoges cedex, 87000
Haute Vienne
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Saint-Cloud, 92210
Hauts De Seine
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Tours Cedex 9, 37044
Indre Et Loire
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Reims Cedex, 51056
Marne
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Albi, 81000
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France
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Angers Cedex 02, 49055
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France
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Avignon Cedex, 84082
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France
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Besancon Cedex, 25030
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France
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Bobigny Cedex, 93009
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France
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Bordeaux Cedex, 33000
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France
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Bordeaux, 33076
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France
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Caen Cedex, 14021
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France
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Clermont-Ferrand, 63011
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France
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Colmar Cedex, 68024
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France
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Corbeil Essonnes, 91100
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France
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Creteil, 94010
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France
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Le Mans Cedex, 72015
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France
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Lyon Cedex 08, 69373
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France
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France
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Marseille, 13273
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France
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France
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Montpellier, 34070
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Paris Cedex 13, 75651
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France
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France
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France
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France
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Paris, 75970
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France
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Reims, 51100
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France
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Strasbourg Cedex, 67010
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France
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France
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Israel
Italy
Novartis Investigative Site
-
Alessandria, 15100
AL
Italy
Novartis Investigative Site
-
Ancona, 60126
AN
Italy
Novartis Investigative Site
-
L'Aquila, 67100
AQ
Italy
Novartis Investigative Site
-
Arezzo, 52100
AR
Italy
Novartis Investigative Site
-
Asti, 14100
AT
Italy
Novartis Investigative Site
-
Avellino, 83100
AV
Italy
Novartis Investigative Site
-
Bari, 70124
BA
Italy
Novartis Investigative Site
-
Bergamo, 24127
BG
Italy
Novartis Investigative Site
-
Treviglio, 24047
BG
Italy
Novartis Investigative Site
-
Benevento, 82100
BN
Italy
Novartis Investigative Site
-
Bologna, 40139
BO
Italy
Novartis Investigative Site
-
Brindisi, 72100
BR
Italy
Novartis Investigative Site
-
Brescia, 25123
BS
Italy
Novartis Investigative Site
-
Brescia, 25124
BS
Italy
Novartis Investigative Site
-
Monserrato, 09042
CA
Italy
Novartis Investigative Site
-
Cuneo, 12100
CN
Italy
Novartis Investigative Site
-
Cremona, 26100
CR
Italy
Novartis Investigative Site
-
Catania, 95124
CT
Italy
Novartis Investigative Site
-
Cona, 44100
FE
Italy
Novartis Investigative Site
-
San Giovanni Rotondo, 71013
FG
Italy
Novartis Investigative Site
-
Firenze, 50134
FI
Italy
Novartis Investigative Site
-
Genova, 16132
GE
Italy
Novartis Investigative Site
-
Grosseto, 58100
GR
Italy
Novartis Investigative Site
-
Lecco, 23900
LC
Italy
Novartis Investigative Site
-
Livorno, 57124
LI
Italy
Novartis Investigative Site
-
Lucca, 55100
LU
Italy
Novartis Investigative Site
-
Monza, 20900
MB
Italy
Novartis Investigative Site
-
Macerata, 62100
MC
Italy
Novartis Investigative Site
-
Messina, 98158
ME
Italy
Novartis Investigative Site
-
Taormina, 98039
ME
Italy
Novartis Investigative Site
-
Milano, 20121
MI
Italy
Novartis Investigative Site
-
Milano, 20132
MI
Italy
Novartis Investigative Site
-
Milano, 20133
MI
Italy
Novartis Investigative Site
-
Milano, 20141
MI
Italy
Novartis Investigative Site
-
Milano, 20162
MI
Italy
Novartis Investigative Site
-
Rozzano, 20089
MI
Italy
Novartis Investigative Site
-
Modena, 41124
MO
Italy
Novartis Investigative Site
-
Nuoro, 08100
NU
Italy
Novartis Investigative Site
-
Palermo, 90127
PA
Italy
Novartis Investigative Site
-
Palermo, 90146
PA
Italy
Novartis Investigative Site
-
Padova, 35100
PD
Italy
Novartis Investigative Site
-
Pisa, 56126
PI
Italy
Novartis Investigative Site
-
Aviano, 33081
PN
Italy
Novartis Investigative Site
-
Prato, 59100
PO
Italy
Novartis Investigative Site
-
Parma, 43100
PR
Italy
Novartis Investigative Site
-
Fano, 61032
PU
Italy
Novartis Investigative Site
-
Reggio Calabria, 89124
RC
Italy
Novartis Investigative Site
-
Reggio Emilia, 42123
RE
Italy
Novartis Investigative Site
-
Roma, 00128
RM
Italy
Novartis Investigative Site
-
Roma, 00152
RM
Italy
Novartis Investigative Site
-
Roma, 00161
RM
Italy
Novartis Investigative Site
-
Roma, 00168
RM
Italy
Novartis Investigative Site
-
Roma, 00189
RM
Italy
Novartis Investigative Site
-
Salerno, 84131
SA
Italy
Novartis Investigative Site
-
Siena, 53100
SI
Italy
Novartis Investigative Site
-
Sassari, 07100
SS
Italy
Novartis Investigative Site
-
Savona, 17100
SV
Italy
Novartis Investigative Site
-
Trento, 38100
TN
Italy
Novartis Investigative Site
-
Candiolo, 10060
TO
Italy
Novartis Investigative Site
-
Torino, 10126
TO
Italy
Novartis Investigative Site
-
Terni, 05100
TR
Italy
Novartis Investigative Site
-
Udine, 33100
UD
Italy
Novartis Investigative Site
-
Saronno, 21047
Va
Italy
Novartis Investigative Site
-
Mirano, 30035
VE
Italy
Novartis Investigative Site
-
Negrar, 37024
VR
Italy
Novartis Investigative Site
-
Verona, 37126
VR
Italy
Novartis Investigative Site
-
Viterbo, 01100
VT
Italy
Novartis Investigative Site
-
Bologna, 40138
-
Italy
Novartis Investigative Site
-
Napoli, 80131
-
Italy
Novartis Investigative Site
-
Napoli, 80138
-
Italy
Novartis Investigative Site
-
Novara, 28100
-
Italy
Novartis Investigative Site
-
Pavia, 27100
-
Italy
Jordan
Novartis Investigative Site
-
Amman, 11941
-
Jordan
Lebanon
Novartis Investigative Site
-
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
-
Beirut,
-
Lebanon
Novartis Investigative Site
-
Saida, 652
-
Lebanon
Malaysia
Novartis Investigative Site
-
Tanjong Bungah, 11200
Penang
Malaysia
Novartis Investigative Site
-
Petaling Jaya, 46050
Selangor
Malaysia
Novartis Investigative Site
-
Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
Novartis Investigative Site
-
Putrajaya, 62250
Wilayah Persekutuan
Malaysia
Novartis Investigative Site
-
Kuala Lumpur, 59100
-
Malaysia
Mexico
Novartis Investigative Site
-
Monterrey, 64710
Nuevo León
Mexico
Novartis Investigative Site
-
Ciudad de Mexico, 04700
-
Mexico
Novartis Investigative Site
-
Mexico City, 01120
-
Mexico
Netherlands
Novartis Investigative Site
-
Maastricht, 5800
AZ
Netherlands
Novartis Investigative Site
-
Venray, 5801
CE
Netherlands
Novartis Investigative Site
-
Apeldoorn, 7334
DZ
Netherlands
Novartis Investigative Site
-
Arnhem, 6815 AD
-
Netherlands
Novartis Investigative Site
-
Beverwijk, 1942 LE
-
Netherlands
Novartis Investigative Site
-
Breda, 4818 CK
-
Netherlands
Novartis Investigative Site
-
Delft, 2625 AD
-
Netherlands
Novartis Investigative Site
-
Den Bosch, 5223 GZ
-
Netherlands
Novartis Investigative Site
-
Den Haag, 2545 CH
-
Netherlands
Novartis Investigative Site
-
Dordrecht, 3318AT
-
Netherlands
Novartis Investigative Site
-
Ede, 6716 RP
-
Netherlands
Novartis Investigative Site
-
Eindhoven, 5623EJ
-
Netherlands
Novartis Investigative Site
-
Enschede, 7513 ER
-
Netherlands
Novartis Investigative Site
-
Goes, 4462 RA
-
Netherlands
Novartis Investigative Site
-
Groningen, 9728 NZ
-
Netherlands
Novartis Investigative Site
-
Hilversum, XZ1213
-
Netherlands
Novartis Investigative Site
-
Hoofddorp, 2134 TM
-
Netherlands
Novartis Investigative Site
-
Leeuwarden, 8934 AD
-
Netherlands
Novartis Investigative Site
-
Roermond, 6043 CV
-
Netherlands
Novartis Investigative Site
-
Rotterdam, 3079 DZ
-
Netherlands
Novartis Investigative Site
-
Sittard-Geleen, 6162 BG
-
Netherlands
Novartis Investigative Site
-
Utrecht, 3543 AZ
-
Netherlands
Novartis Investigative Site
-
Zutphen, 7207 AE
-
Netherlands
Novartis Investigative Site
-
Zwolle, 8025 AB
-
Netherlands
Norway
Novartis Investigative Site
-
Gralum, 1714
-
Norway
Novartis Investigative Site
-
Oslo, 0379
-
Norway
Novartis Investigative Site
-
Oslo, NO 0450
-
Norway
Novartis Investigative Site
-
Stavanger, NO-4068
-
Norway
Oman
Novartis Investigative Site
-
Muscat, 123
-
Oman
Panama
Novartis Investigative Site
-
Panama City,
-
Panama
Philippines
Novartis Investigative Site
-
Taguig City, 1634
Metro Manila
Philippines
Novartis Investigative Site
-
Las Pinas, 1740
-
Philippines
Novartis Investigative Site
-
San Juan City, 1500
-
Philippines
Poland
Novartis Investigative Site
-
Zory, 44-240
Slaskie
Poland
Novartis Investigative Site
-
Bydgoszcz, 85 796
-
Poland
Novartis Investigative Site
-
Bytom, 41-902
-
Poland
Novartis Investigative Site
-
Gdansk, 80 952
-
Poland
Novartis Investigative Site
-
Krakow, 31-501
-
Poland
Novartis Investigative Site
-
Lublin, 20 090
-
Poland
Novartis Investigative Site
-
Opole, 45-061
-
Poland
Novartis Investigative Site
-
Rzeszow, 35-021
-
Poland
Novartis Investigative Site
-
Warszawa, 02 781
-
Poland
Novartis Investigative Site
-
Wroclaw, 53 413
-
Poland
Portugal
Novartis Investigative Site
-
Braga, 4710243
-
Portugal
Novartis Investigative Site
-
Guimaraes, 4835-044
-
Portugal
Novartis Investigative Site
-
Lisboa, 1400-038
-
Portugal
Novartis Investigative Site
-
Lisboa, 1500 650
-
Portugal
Novartis Investigative Site
-
Lisboa, 1649-035
-
Portugal
Novartis Investigative Site
-
Lisboa, 1998-018
-
Portugal
Novartis Investigative Site
-
Porto, 4099-001
-
Portugal
Novartis Investigative Site
-
Porto, 4200-072
-
Portugal
Novartis Investigative Site
-
Porto, 4200-319
-
Portugal
Russian Federation
Novartis Investigative Site
-
Leningrad Region, 188663
Russia
Russian Federation
Novartis Investigative Site
-
Kazan, 420029
Tatarstan Republic
Russian Federation
Novartis Investigative Site
-
Chelyabinsk, 454087
-
Russian Federation
Novartis Investigative Site
-
Irkutsk, 664035
-
Russian Federation
Novartis Investigative Site
-
Kaluga, 248007
-
Russian Federation
Novartis Investigative Site
-
Krasnoyarsk, 660022
-
Russian Federation
Novartis Investigative Site
-
Moscow Rerion Balashiha, 143900
-
Russian Federation
Novartis Investigative Site
-
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
-
Moscow, 125284
-
Russian Federation
Novartis Investigative Site
-
Moscow, 143423
-
Russian Federation
Novartis Investigative Site
-
Rostov-na-Donu, 344037
-
Russian Federation
Novartis Investigative Site
-
Samara, 443031
-
Russian Federation
Novartis Investigative Site
-
St Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
-
St Petersburg, 197758
-
Russian Federation
Novartis Investigative Site
-
Ufa, 450054
-
Russian Federation
Novartis Investigative Site
-
Yaroslavl, 150054
-
Russian Federation
Saudi Arabia
Novartis Investigative Site
-
Dammam, 15215
-
Saudi Arabia
Novartis Investigative Site
-
Makkah, 57657
-
Saudi Arabia
Novartis Investigative Site
-
Riyadh, 11211
-
Saudi Arabia
Novartis Investigative Site
-
Riyadh, 11426
-
Saudi Arabia
Singapore
Novartis Investigative Site
-
Singapore, 217562
-
Singapore
Novartis Investigative Site
-
Singapore, 258500
-
Singapore
Novartis Investigative Site
-
Singapore, 308433
-
Singapore
Slovakia
Novartis Investigative Site
-
Banska Bystrica, 97401
Slovak Republic
Slovakia
Novartis Investigative Site
-
Kosice, 04191
-
Slovakia
Novartis Investigative Site
-
Poprad, 058 01
-
Slovakia
Slovenia
Novartis Investigative Site
-
Ljubljana, 1000
-
Slovenia
Novartis Investigative Site
-
Maribor, 2000
-
Slovenia
Spain
Novartis Investigative Site
-
Elche, 03203
Alicante
Spain
Novartis Investigative Site
-
Almeria, 04009
Andalucia
Spain
Novartis Investigative Site
-
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
-
Granada, 18014
Andalucia
Spain
Novartis Investigative Site
-
Huelva, 21005
Andalucia
Spain
Novartis Investigative Site
-
Jaen, 23007
Andalucia
Spain
Novartis Investigative Site
-
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
-
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
-
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
-
Sevilla, 41014
Andalucia
Spain
Novartis Investigative Site
-
Sabadell, 08208
Barcelona
Spain
Novartis Investigative Site
-
Jerez, 11407
Cadiz
Spain
Novartis Investigative Site
-
Toledo, 45071
Castilla La Mancha
Spain
Novartis Investigative Site
-
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
-
Lleida, 25198
Cataluna
Spain
Novartis Investigative Site
-
Badalona, 08916
Catalunya
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
-
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
-
Girona, 17007
Catalunya
Spain
Novartis Investigative Site
-
Hospitalet de LLobregat, 08907
Catalunya
Spain
Novartis Investigative Site
-
Barcelona, 08024
Cataluña
Spain
Novartis Investigative Site
-
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Alicante, 03550
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Castellon, 12002
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Valencia, 46009
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Valencia, 46014
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Valencia, 46015
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Badajoz, 06080
Extremadura
Spain
Novartis Investigative Site
-
Caceres, 10003
Extremadura
Spain
Novartis Investigative Site
-
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
-
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
-
Palma De Mallorca, 07120
Islas Baleares
Spain
Novartis Investigative Site
-
Las Palmas De Gran Canarias, 35016
Las Palmas De Gran Canaria
Spain
Novartis Investigative Site
-
El Palmar, 30120
Murcia
Spain
Novartis Investigative Site
-
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
-
Bilbao, 48013
Pais Vasco
Spain
Novartis Investigative Site
-
San Sebastian, 20080
Pais Vasco
Spain
Novartis Investigative Site
-
Vigo, 36212
Pontevedra
Spain
Novartis Investigative Site
-
La Laguna, 38320
Santa Cruz De Tenerife
Spain
Novartis Investigative Site
-
Reus, 43201
Tarragona
Spain
Novartis Investigative Site
-
Barcelona, 08041
-
Spain
Novartis Investigative Site
-
Burgos, 09006
-
Spain
Novartis Investigative Site
-
Granollers, 08402
-
Spain
Novartis Investigative Site
-
Madrid, 28006
-
Spain
Novartis Investigative Site
-
Madrid, 28009
-
Spain
Novartis Investigative Site
-
Madrid, 28034
-
Spain
Novartis Investigative Site
-
Madrid, 28040
-
Spain
Novartis Investigative Site
-
Madrid, 28041
-
Spain
Novartis Investigative Site
-
Madrid, 28046
-
Spain
Novartis Investigative Site
-
Madrid, 28222
-
Spain
Novartis Investigative Site
-
Murcia, 30008
-
Spain
Novartis Investigative Site
-
Valencia, 46026
-
Spain
Novartis Investigative Site
-
Zaragoza, 50009
-
Spain
Sweden
Novartis Investigative Site
-
Gothenburg, SE-431 45
-
Sweden
Novartis Investigative Site
-
Orebro, 701 85
-
Sweden
Novartis Investigative Site
-
Stockholm, SE-118 83
-
Sweden
Novartis Investigative Site
-
Uppsala, 751 85
-
Sweden
Novartis Investigative Site
-
Vaxjo, SE-351 85
-
Sweden
Taiwan
Novartis Investigative Site
-
Taichung, 40447
-
Taiwan
Novartis Investigative Site
-
Tainan, 70403
-
Taiwan
Novartis Investigative Site
-
Taipei, 114
-
Taiwan
Thailand
Novartis Investigative Site
-
Songkhla, 90110
Hat Yai
Thailand
Novartis Investigative Site
-
Khon Kaen, 40002
THA
Thailand
Novartis Investigative Site
-
Bangkok, 10400
-
Thailand
Novartis Investigative Site
-
Chiang Mai, 50200
-
Thailand
United Kingdom
Novartis Investigative Site
-
Peterborough, PE3 9GZ
Cambridgeshire
United Kingdom
Novartis Investigative Site
-
Truro, TR1 3LJ
Cornwall
United Kingdom
Novartis Investigative Site
-
Portsmouth, PO6 3LY
Hants
United Kingdom
Novartis Investigative Site
-
Maidstone, ME16 9QQ
Kent
United Kingdom
Novartis Investigative Site
-
York, YO31 8HE
North Yorkshire
United Kingdom
Novartis Investigative Site
-
Aberdeen, AB25 2ZN
Scotland
United Kingdom
Novartis Investigative Site
-
Ipswich, IP4 5PD
Suffolk
United Kingdom
Novartis Investigative Site
-
Guildford, GU2 7XX
Surrey
United Kingdom
Novartis Investigative Site
-
Sutton, SM2 5PT
Surrey
United Kingdom
Novartis Investigative Site
-
Bristol, BS2 8ED
-
United Kingdom
Novartis Investigative Site
-
Cardiff, CF14 2TL
-
United Kingdom
Novartis Investigative Site
-
East Sussex, BN2 5BE
-
United Kingdom
Novartis Investigative Site
-
Edinburgh, EH4 2XU
-
United Kingdom
Novartis Investigative Site
-
Exeter, EX2 5DW
-
United Kingdom
Novartis Investigative Site
-
Glasgow, G12 0YN
-
United Kingdom
Novartis Investigative Site
-
Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
-
Leicester, LE1 5WW
-
United Kingdom
Novartis Investigative Site
-
London, NW1 2PJ
-
United Kingdom
Novartis Investigative Site
-
London, SW3 6JJ
-
United Kingdom
Novartis Investigative Site
-
London, W8 6RF
-
United Kingdom
Novartis Investigative Site
-
Manchester, M20 4BX
-
United Kingdom
Novartis Investigative Site
-
Newcastle upon Tyne, NE7 7DN
-
United Kingdom
Novartis Investigative Site
-
Nottingham, NG5 1PB
-
United Kingdom
Novartis Investigative Site
-
Oxford, OX3 7LJ
-
United Kingdom
Novartis Investigative Site
-
Plymouth, PL6 8DH
-
United Kingdom
Novartis Investigative Site
-
Preston, PR2 9HT
-
United Kingdom
Novartis Investigative Site
-
Sheffield, S10 2SJ
-
United Kingdom
Novartis Investigative Site
-
Stoke-on-Trent, ST4 6QG
-
United Kingdom

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