Clinical trial NCT00056407: "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms, Prostate
Keywords: Prostate cancer prevention
prostate
BPH
enlarged prostate
PSA
prostate cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-03-13
Enrollment: 8231
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Eligibility criteria: Inclusion criteria:

* Informed consent to participate in study.
* Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
* Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
* Ability and will to participate in study for 4 years.

Exclusion criteria:

* More than one previous negative prostate biopsy.
* History of prostate cancer.
* Previous prostate surgery.
* Inability to urinate requiring the need of a catheter during the previous 2 years.
* Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
* Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
* Any unstable serious medical condition.
* Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Primary outcomes:
measure: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
timeFrame: Years 1-2, Years 3-4, and Overall (Years 1-4)
measure: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
timeFrame: Years 1-2, Years 3-4, and Overall (Years 1-4)
measure: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
timeFrame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Secondary outcomes:
measure: Number of Participants With the Indicated Gleason Score at Diagnosis
timeFrame: Baseline to Year 4
measure: Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
timeFrame: Baseline to Year 4
measure: Volume of HGPIN at Biopsy
timeFrame: Baseline to Year 4
measure: Percentage of Core Involved at Diagnosis
timeFrame: Baseline to Year 4
measure: Number of Cancer-positive Cores
timeFrame: Baseline to Year 4
measure: Treatment Alteration Score
timeFrame: Baseline to Year 4
measure: Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
timeFrame: Baseline to Year 4
measure: Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
timeFrame: Baseline to Year 4 (Month 48)
measure: Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
timeFrame: Baseline, Month 24, and Month 48
measure: Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
timeFrame: Years 1-2, Overall (Years 1-4)
measure: Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
timeFrame: Years 1-2 and Overall (Years 1-4)
measure: Number of Participants With at Least One Urinary Tract Infection (UTI)
timeFrame: Years 1-2, Years 3-4, and Overall (Years 1-4)
measure: Number of Participants With Post-biopsy Macroscopic Hematuria
timeFrame: Baseline to Year 4
measure: Number of Participants With Post-biopsy Macroscopic Hematospermia
timeFrame: Baseline through Year 4
measure: Overall Survival
timeFrame: From time informed consent is signed to 4-month Safety Follow-Up period
measure: Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
timeFrame: Baseline and Month 48
measure: Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
timeFrame: Baseline and Month 48
measure: Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
timeFrame: Baseline and Month 48
measure: Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
timeFrame: Baseline and Month 48
measure: Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
timeFrame: Baseline and Month 48
measure: Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
timeFrame: Month 48
measure: Mean Change From Baseline in Testosterone at Month 48
timeFrame: Baseline and Month 48
Other outcomes:
Locations:
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country: United States
facility: GSK Investigational Site
state: Alabama
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country: United States
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city: Detroit
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country: United States
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country: United States
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country: United States
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facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
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state: South Carolina
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Amiens
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muelheim
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Oberhausen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Nordrhein-Westfalen
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facility: GSK Investigational Site
state: Rheinland-Pfalz
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facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dierdorf
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facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Koblenz
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facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Nieder-Olm
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facility: GSK Investigational Site
state: Rheinland-Pfalz
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facility: GSK Investigational Site
state: Saarland
city: Dessau
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facility: GSK Investigational Site
state: Sachsen-Anhalt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Eisleben
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Gardelegen
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facility: GSK Investigational Site
state: Sachsen-Anhalt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Hettstedt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Weissenfels
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Wolmirstedt
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facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Bautzen
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facility: GSK Investigational Site
state: Sachsen
city: Chemnitz
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facility: GSK Investigational Site
state: Sachsen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Doebeln
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
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facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Grimma
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facility: GSK Investigational Site
state: Sachsen
city: Leipzig
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facility: GSK Investigational Site
state: Sachsen
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facility: GSK Investigational Site
state: Sachsen
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facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
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facility: GSK Investigational Site
state: Sachsen
city: Markkleeberg
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facility: GSK Investigational Site
state: Sachsen
city: Neustadt
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facility: GSK Investigational Site
state: Sachsen
city: Oelsnitz
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facility: GSK Investigational Site
state: Sachsen
city: Pirna
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facility: GSK Investigational Site
state: Sachsen
city: Plauen
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facility: GSK Investigational Site
state: Sachsen
city: Radebeul
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facility: GSK Investigational Site
state: Sachsen
city: Schlema
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facility: GSK Investigational Site
state: Sachsen
city: Schwarzenberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Wilkau-Hasslau
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facility: GSK Investigational Site
state: Sachsen
city: Zwickau
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facility: GSK Investigational Site
state: Sachsen
city: Ahrensburg
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facility: GSK Investigational Site
state: Schleswig-Holstein
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Hemmoor
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Itzehoe
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Kiel
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Lauenburg
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Ploen
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schleswig
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facility: GSK Investigational Site
state: Schleswig-Holstein
city: Gera
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facility: GSK Investigational Site
state: Thueringen
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facility: GSK Investigational Site
state: Thueringen
city: Ilmenau
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facility: GSK Investigational Site
state: Thueringen
city: Meiningen
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facility: GSK Investigational Site
state: Thueringen
city: Waltershausen
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facility: GSK Investigational Site
state: Thueringen
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Berlin
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Athens
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facility: GSK Investigational Site
city: Athens
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facility: GSK Investigational Site
city: Heraklion, Crete
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facility: GSK Investigational Site
city: Ioannina
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facility: GSK Investigational Site
city: Larisa
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facility: GSK Investigational Site
city: Periohi Dragana, Alexandroupolis
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facility: GSK Investigational Site
city: Rhodes
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facility: GSK Investigational Site
city: Rio, Patras
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facility: GSK Investigational Site
city: Thessaloniki
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facility: GSK Investigational Site
city: Thessaloniki
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facility: GSK Investigational Site
city: Budapest
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facility: GSK Investigational Site
city: Budapest
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facility: GSK Investigational Site
city: Győr
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facility: GSK Investigational Site
city: Kecskemét
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facility: GSK Investigational Site
city: Miskolc
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facility: GSK Investigational Site
city: Cork
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facility: GSK Investigational Site
city: Dublin
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facility: GSK Investigational Site
city: Tallaght
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facility: GSK Investigational Site
city: Lanciano (CH)
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facility: GSK Investigational Site
state: Abruzzo
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facility: GSK Investigational Site
state: Campania
city: Napoli
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facility: GSK Investigational Site
state: Campania
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facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
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facility: GSK Investigational Site
state: Lazio
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facility: GSK Investigational Site
state: Lombardia
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facility: GSK Investigational Site
state: Lombardia
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facility: GSK Investigational Site
state: Lombardia
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facility: GSK Investigational Site
state: Puglia
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facility: GSK Investigational Site
state: Sardegna
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facility: GSK Investigational Site
state: Sardegna
city: Catania
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facility: GSK Investigational Site
state: Sicilia
city: Ragusa (CT)
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facility: GSK Investigational Site
state: Sicilia
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facility: GSK Investigational Site
state: Toscana
city: Isola della Scala (VR)
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facility: GSK Investigational Site
state: Veneto
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facility: GSK Investigational Site
state: Veneto
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facility: GSK Investigational Site
city: Fukuoka
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facility: GSK Investigational Site
city: Hokkaido
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facility: GSK Investigational Site
city: Ibaraki
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facility: GSK Investigational Site
city: Nagasaki
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facility: GSK Investigational Site
city: Oita
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facility: GSK Investigational Site
city: Daugavpils
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Siauliai
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Vilnius
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facility: GSK Investigational Site
city: Vilnius
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facility: GSK Investigational Site
city: Zapopan, Jalisco
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Jalisco
city: Zapopan
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facility: GSK Investigational Site
state: Jalisco
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facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: México, City
country: Mexico
facility: GSK Investigational Site
city: Puebla
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facility: GSK Investigational Site
city: Amsterdam
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facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Arnhem
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facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Capelle Aan Den Ijssel
country: Netherlands
facility: GSK Investigational Site
city: Den Bosch
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
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facility: GSK Investigational Site
city: EDE
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facility: GSK Investigational Site
city: Eindhoven
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facility: GSK Investigational Site
city: Harderwijk
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facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Nieuwegein
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facility: GSK Investigational Site
city: Nijmegen
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facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Roermond
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facility: GSK Investigational Site
city: Roosendaal
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facility: GSK Investigational Site
city: Rotterdam
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facility: GSK Investigational Site
city: Rotterdam
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facility: GSK Investigational Site
city: Stadskanaal
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facility: GSK Investigational Site
city: Tilburg
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facility: GSK Investigational Site
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city: Christchurch
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Tauranga
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Arendal
country: Norway
facility: GSK Investigational Site
city: Moelv
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facility: GSK Investigational Site
city: Oslo
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facility: GSK Investigational Site
city: Porsgrunn
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facility: GSK Investigational Site
city: Stavanger
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facility: GSK Investigational Site
city: Bydgoszcz
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facility: GSK Investigational Site
city: Bydgoszcz
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facility: GSK Investigational Site
city: Checiny
country: Poland
facility: GSK Investigational Site
city: Elblag
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facility: GSK Investigational Site
city: Gdansk
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facility: GSK Investigational Site
city: Inowroclaw
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facility: GSK Investigational Site
city: Katowice
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facility: GSK Investigational Site
city: Koscierzyna
country: Poland
facility: GSK Investigational Site
city: Krakow
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facility: GSK Investigational Site
city: Lublin
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facility: GSK Investigational Site
city: Rzeszow
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Wejherowo
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facility: GSK Investigational Site
city: Wroclaw
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Amadora
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facility: GSK Investigational Site
city: Lisboa
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facility: GSK Investigational Site
city: Porto
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facility: GSK Investigational Site
city: Porto
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facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
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city: San Juan
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facility: GSK Investigational Site
city: San Juan
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
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country: Russian Federation
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Capital Park
country: South Africa
facility: GSK Investigational Site
city: George
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
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facility: GSK Investigational Site
city: Parktown
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Westville, Durban
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facility: GSK Investigational Site
city: Alava
country: Spain
facility: GSK Investigational Site
city: Alcala De Henares (Madrid)
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facility: GSK Investigational Site
city: Alcorcon
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Castellón
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facility: GSK Investigational Site
city: Ciudad Real
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Galdakano
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Ibiza
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facility: GSK Investigational Site
city: Jaen
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facility: GSK Investigational Site
city: La Laguna (Santa Cruz de Tenerife)
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facility: GSK Investigational Site
city: Leganes
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Madrid
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Pamplona
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facility: GSK Investigational Site
city: Sagunto
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Sweden
facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Karlshamn
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Skärholmen
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Tunisia
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Zaporizhzhya
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Somerset
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Sussex West
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facility: GSK Investigational Site
state: Warwickshire
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facility: GSK Investigational Site
state: Warwickshire
city: Bradford
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Clydebank, Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Crewe
country: United Kingdom
facility: GSK Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Falkirk
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
city: Torquay
country: United Kingdom
facility: GSK Investigational Site
city: Wakefield
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Wolverhampton
country: United Kingdom
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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citation: Marberger M, Wilson TH, Rittmaster RS. Low serum testosterone levels are poor predictors of sexual dysfunction. BJU Int. 2011 Jul;108(2):256-62. doi: 10.1111/j.1464-410X.2010.09766.x. Epub 2010 Oct 18.
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citation: Stephen J. Freedland, Leah Gerber, Lionel Banez, Daniel Moreira, Gerald L. Andriole, and Roger S. Rittmaster on behalf of the REDUCE Study Group. Statin Use and the Risk of Prostate Cancer and High-grade Prostate Cancer: Results from the REDUCE study. [AUA 2011 Annual Meeting]. 2011;185(4 Suppl):e135.
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