Clinical trial NCT01215942: An Open Label Study for Participants With Rheumatoid Arthritis
Official title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 1086
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

Detailed description: Week 16 non-responders (NR) are participants with \<20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Eligibility criteria: Inclusion Criteria:

* Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
* Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

* Current presence of a serious disorder or illness

Primary outcomes:
measure: Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
timeFrame: up to 84.4 weeks during treatment period
measure: Percentage of Participants Developing Anti-LY2127399 Antibodies
timeFrame: Baseline through Weeks 4, 24, 48 and 72
measure: Change From Baseline in Absolute B Cell Counts
timeFrame: Baseline, Week 48
measure: Change From Baseline in Serum Immunoglobulin (Ig) Levels
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
timeFrame: Baseline through Weeks 12, 24 and 48
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
timeFrame: Baseline, 240 weeks
measure: Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
timeFrame: Baseline through 240 weeks
measure: Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Tender Joint Count (68 Joint Count)
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Swollen Joint Count (66 Joint Count)
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Participants Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, 240 weeks
measure: Change From Baseline in CRP
timeFrame: Baseline, 240 weeks
measure: American College of Rheumatology Percent Improvement (ACR-N)
timeFrame: Baseline through 240 weeks
Other outcomes:
measure: Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period
timeFrame: Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period
Locations:
city: Birmingham
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Huntsville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Peoria
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Phoenix
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Scottsdale
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Tucson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Hot Springs
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arkansas
city: Jonesboro
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arkansas
city: Little Rock
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arkansas
city: Escondido
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Fresno
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Hemet
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Huntington Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: La Jolla
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: La Mesa
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Loma Linda
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Long Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Los Angeles
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Sacramento
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: San Diego
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Santa Monica
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Torrance
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Upland
country: United States
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state: California
city: Wildomar
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Colorado
city: Lewes
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Delaware
city: Aventura
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Boca Raton
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Boynton Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: DeBary
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Miami
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: New Port Richey
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Palm Harbor
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Pinellas Park
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Saint Petersburg
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Tamarac
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Tampa
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Venice
country: United States
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state: Florida
city: Vero Beach
country: United States
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state: Florida
city: West Palm Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Zephyrhills
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Decatur
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Dunwoody
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Gainesville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Lawrenceville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Marietta
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Savannah
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Stockbridge
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Eagle
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Idaho
city: Idaho Falls
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Idaho
city: Morton Grove
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Peoria
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Rockford
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Brownsburg
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
city: Evansville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
city: Kansas City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Kansas
city: Shawnee Mission
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Kansas
city: Wichita
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Kansas
city: Bowling Green
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Kentucky
city: Owensboro
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Kentucky
city: Monroe
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Louisiana
city: Cumberland
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
city: Wheaton
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
city: Haverhill
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Massachusetts
city: Worcester
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Massachusetts
city: Bingham Farms
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Michigan
city: Saint Clair Shores
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Michigan
city: Flowood
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Mississippi
city: Jackson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Mississippi
city: Florissant
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Missouri
city: Saint Louis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Missouri
city: Kalispell
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Montana
city: Lincoln
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nebraska
city: Omaha
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nebraska
city: Las Vegas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nevada
city: Nashua
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New Hampshire
city: Berkeley Heights
country: United States
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state: New Jersey
city: Clifton
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Brooklyn
country: United States
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state: New York
city: Roslyn
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Hickory
country: United States
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Sanford
country: United States
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state: North Carolina
city: Bismarck
country: United States
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state: North Dakota
city: Cincinnati
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Bend
country: United States
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state: Oregon
city: Bethlehem
country: United States
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state: Pennsylvania
city: Erie
country: United States
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state: Pennsylvania
city: Limerick
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pottstown
country: United States
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state: Pennsylvania
city: Columbia
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Greer
country: United States
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state: South Carolina
city: Myrtle Beach
country: United States
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state: South Carolina
city: North Charleston
country: United States
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state: South Carolina
city: Taylors
country: United States
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state: South Carolina
city: Knoxville
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Lake Jackson
country: United States
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state: Texas
city: Lubbock
country: United States
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state: Texas
city: Mesquite
country: United States
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state: Texas
city: Nassau Bay
country: United States
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state: Texas
city: North Richland Hills
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Burlington
country: United States
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state: Vermont
city: Richmond
country: United States
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state: Virginia
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Wenatchee
country: United States
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state: Washington
city: Clarksburg
country: United States
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state: West Virginia
city: Milwaukee
country: United States
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state: Wisconsin
city: Racine
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Córdoba
country: Argentina
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city: Lujan
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Quilmes
country: Argentina
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city: Rosario
country: Argentina
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city: San Juan
country: Argentina
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city: Tucuman
country: Argentina
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city: Campbelltown
country: Australia
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state: New South Wales
city: Kogarah
country: Australia
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state: New South Wales
city: Herston
country: Australia
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state: Queensland
city: Malvern East
country: Australia
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city: Campinas
country: Brazil
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city: Caxias Do Sul
country: Brazil
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city: Curitiba
country: Brazil
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city: Fortaleza
country: Brazil
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city: Juiz De Fora
country: Brazil
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city: Rio De Janeiro
country: Brazil
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city: Setor Oeste/Goiania
country: Brazil
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city: São Paulo
country: Brazil
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city: Burgas
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Rousse
country: Bulgaria
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city: Sevlievo
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Varna
country: Bulgaria
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city: Bogota
country: Colombia
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city: Medellin
country: Colombia
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city: Opatija
country: Croatia
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city: Osijek
country: Croatia
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city: Rijeka
country: Croatia
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city: Montpellier
country: France
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city: Nice
country: France
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city: Orleans
country: France
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city: Paris
country: France
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city: Saint-Etienne Cedex 02
country: France
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city: Strasbourg
country: France
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city: Toulouse
country: France
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city: Bad Doberan
country: Germany
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city: Bad Nauheim
country: Germany
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city: Baden-Baden
country: Germany
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city: Berlin
country: Germany
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city: Dresden
country: Germany
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city: Erlangen
country: Germany
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city: Frankfurt
country: Germany
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city: Göttingen
country: Germany
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city: Koeln
country: Germany
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city: Munich
country: Germany
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city: Haidari/Athens
country: Greece
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city: Heraklion
country: Greece
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city: Larissa
country: Greece
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city: Thessaloniki
country: Greece
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city: Baja
country: Hungary
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city: Balassagyarmat
country: Hungary
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city: Budapest
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Debrecen
country: Hungary
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city: Esztergom
country: Hungary
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city: Kiskunhalas
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Satoraljaujhely
country: Hungary
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city: Szikszo
country: Hungary
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city: Veszprem
country: Hungary
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city: Ahmedabad
country: India
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city: Bangalore
country: India
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city: Chennai
country: India
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city: Hyderabaad
country: India
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city: Jaipur
country: India
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city: Lucknow
country: India
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city: Mysore
country: India
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city: Nellore
country: India
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city: New Delhi
country: India
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city: Secunderabad
country: India
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city: Surat
country: India
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city: Aichi
country: Japan
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city: Chiba
country: Japan
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city: Fukuoka
country: Japan
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city: Gunma
country: Japan
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city: Hokkaido
country: Japan
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city: Hyogo
country: Japan
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city: Ibaragi
country: Japan
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city: Ibaraki
country: Japan
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city: Japan
country: Japan
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city: Kagoshima
country: Japan
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Mie
country: Japan
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city: Miyagi
country: Japan
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city: Miyazaki
country: Japan
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city: Nagano
country: Japan
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city: Nagasaki
country: Japan
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city: Nara
country: Japan
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city: Ohita
country: Japan
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city: Okayama
country: Japan
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city: Osaka
country: Japan
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city: Saga
country: Japan
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city: Saitama
country: Japan
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city: Sapporo-Shi
country: Japan
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city: Shizuoka
country: Japan
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city: Tokushima
country: Japan
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city: Tokyo
country: Japan
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city: Toyama
country: Japan
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city: Busan
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Daegu
country: Korea, Republic of
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city: Daejeon
country: Korea, Republic of
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city: Incheon
country: Korea, Republic of
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city: Seongnam-Si
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Suwon-City
country: Korea, Republic of
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city: Alytus
country: Lithuania
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city: Kaunas
country: Lithuania
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city: Klaipedos
country: Lithuania
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city: Siauliai
country: Lithuania
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city: Vilnius
country: Lithuania
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city: Batu Caves
country: Malaysia
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city: Kota Bahru
country: Malaysia
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city: Kuantan Pahang
country: Malaysia
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city: Perak
country: Malaysia
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city: Putrajaya
country: Malaysia
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city: Sarawak
country: Malaysia
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city: Aguascalientes
country: Mexico
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city: Barrio San Mateo
country: Mexico
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city: Chihuahua
country: Mexico
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city: Guadalajara
country: Mexico
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city: Mexicali
country: Mexico
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Morelia
country: Mexico
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city: Queretaro
country: Mexico
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city: San Luis Potosi
country: Mexico
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city: Tijuana
country: Mexico
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city: Hamilton
country: New Zealand
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city: Rotorua
country: New Zealand
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city: Tauranga
country: New Zealand
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city: Timaru
country: New Zealand
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city: Bydgoszcz
country: Poland
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city: Dzialdowo
country: Poland
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city: Elblag
country: Poland
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city: Gdynia
country: Poland
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city: Krakow
country: Poland
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city: Lublin
country: Poland
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city: Plock
country: Poland
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city: Torun
country: Poland
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city: Warsaw
country: Poland
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city: Wloszczowa
country: Poland
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city: Brasov
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cluj-Napoca
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Iasi
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ploiesti
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Barnaul
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kazan
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kemerovo
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Khanty-Mansiysk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kursk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nizhny Novgorod
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Novosibirsk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Petrozavodsk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ryazan
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Saratov
country: Russian Federation
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city: Stavropol
country: Russian Federation
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city: Voronezh
country: Russian Federation
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city: Yaroslavl
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bratislava
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Dunajska Streda
country: Slovakia
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city: Piestany
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Benoni
country: South Africa
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city: Bloemfontein
country: South Africa
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city: Breyten
country: South Africa
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
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city: Limpopo
country: South Africa
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city: Pretoria
country: South Africa
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city: Somerset West
country: South Africa
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city: Stellenbosch
country: South Africa
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city: Barcelona
country: Spain
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city: Bilboa
country: Spain
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city: La Coruña
country: Spain
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city: Madrid
country: Spain
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city: San Sebastian
country: Spain
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city: Colombo
country: Sri Lanka
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city: Galle
country: Sri Lanka
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city: Kalubowila
country: Sri Lanka
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city: Nugegoda
country: Sri Lanka
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city: Keelung
country: Taiwan
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city: Kuei Shan Hsiang
country: Taiwan
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city: Niao Sung Hsiang
country: Taiwan
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city: Taichung
country: Taiwan
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city: Taipei
country: Taiwan
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city: Dnipropetrovsk
country: Ukraine
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city: Donetsk
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kiev
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Odesa
country: Ukraine
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city: Poltava
country: Ukraine
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city: Simferopol
country: Ukraine
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city: Vinnitsa
country: Ukraine
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city: Vinnytsya
country: Ukraine
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Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: