ClinicalTrials.gov
History of Changes for Study: NCT02125461
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)
Latest version (submitted September 21, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 25, 2014 None (earliest Version on record)
2 May 20, 2014 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Oversight
3 June 4, 2014 Study Status and References
4 August 19, 2014 Contacts/Locations, Study Status and Study Design
5 September 15, 2014 Contacts/Locations and Study Status
6 November 19, 2014 Contacts/Locations and Study Status
7 December 19, 2014 Contacts/Locations and Study Status
8 January 28, 2015 Contacts/Locations, Study Status and Arms and Interventions
9 March 25, 2015 Study Status
10 May 29, 2015 Contacts/Locations, Study Status and Outcome Measures
11 June 29, 2015 Contacts/Locations and Study Status
12 July 27, 2015 Contacts/Locations and Study Status
13 July 28, 2015 Study Status
14 August 18, 2015 Study Status and Contacts/Locations
15 September 11, 2015 Contacts/Locations and Study Status
16 October 20, 2015 Contacts/Locations, Study Status and Eligibility
17 November 16, 2015 Contacts/Locations and Study Status
18 December 15, 2015 Contacts/Locations and Study Status
19 January 11, 2016 Contacts/Locations and Study Status
20 February 11, 2016 Contacts/Locations and Study Status
21 April 7, 2016 Recruitment Status, Contacts/Locations, Study Status and Outcome Measures
22 July 1, 2016 Contacts/Locations and Study Status
23 September 1, 2016 Study Status and Contacts/Locations
24 November 25, 2016 Study Status and Contacts/Locations
25 February 24, 2017 Study Status and Study Design
26 May 1, 2017 Study Status, Contacts/Locations, Oversight and Study Design
27 May 11, 2017 Study Status and Study Design
28 June 22, 2017 Contacts/Locations, Study Status and Study Design
29 January 12, 2018 Contacts/Locations, Study Status
Show
Results Submission Events
30 January 28, 2019 Contacts/Locations, Outcome Measures, Study Status, Document Section, Results and References
31 March 20, 2019 Outcome Measures, Adverse Events, Participant Flow, Document Section, Baseline Characteristics, Study Status, More Information and Contacts/Locations
32 June 21, 2019 Contacts/Locations and Study Status
33 September 16, 2019 Study Status and Contacts/Locations
34 December 17, 2019 Contacts/Locations and Study Status
35 March 18, 2020 Contacts/Locations and Study Status
36 September 3, 2020 Study Status, IPDSharing and Contacts/Locations
37 May 11, 2021 Contacts/Locations and Study Status
38 September 6, 2021 Contacts/Locations and Study Status
39 November 3, 2021 Adverse Events, Participant Flow, Outcome Measures, Document Section, More Information, References, Study Status and Contacts/Locations
40 January 17, 2022 Study Status
41 April 12, 2022 Study Status
42 August 16, 2022 Contacts/Locations and Study Status
43 November 9, 2022 Study Status
44 January 4, 2023 Study Status
45 April 5, 2023 Study Status
46 June 28, 2023 Study Status and Study Identification
47 September 21, 2023 Recruitment Status and Study Status
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Study NCT02125461
Submitted Date:  May 29, 2015 (v10)
Open or close this module Study Identification
Unique Protocol ID: D4191C00001
Brief Title: A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)
Official Title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2015
Overall Status: Recruiting
Study Start: May 2014
Primary Completion: May 2017 [Anticipated]
Study Completion: January 2020 [Anticipated]
First Submitted: April 25, 2014
First Submitted that
Met QC Criteria:		 April 25, 2014
First Posted: April 29, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 29, 2015
Last Update Posted: June 1, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
Detailed Description: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords: Locally advanced
Unresectable Non-Small Cell Lung Cancer
MEDI4736
PD-L1
Stage III Non-Small Cell Lung Cancer
Chemoradiation
Immune-mediated cancer therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 702 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MEDI4736
MEDI4736 (intravenous infusion)
 Drug: MEDI4736
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Placebo Comparator: PLACEBO
Placebo (matching placebo for intravenous infusion)
PLACEBO
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Estimated to be from baseline up to 5 years ]

Overall Survival is defined as the time from the date of randomization until death due to any cause.
2. Progression Free Survival (PFS) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be from baseline up to 5 years ]

Progression-Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
Secondary Outcome Measures:
1. Overall Survival at 24 months (OS24)
[ Time Frame: Estimated to be from baseline up to 5 years ]

OS24 is defined as the number (%) of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months.
2. Duration of Response (DoR) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 3 years ]

DoR is defined as the time from date for first documented response of Complete Response (CR) or Partial Response (PR) until the first documented response of progression per RECIST 1.1 or death in the absence of progression.
3. Objective Response Rate (ORR) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 3 years ]

ORR is defined as the number (%) of patients with at least one visit response of Complete Response (CR) or partial response (PR) per RECIST 1.1.
4. Proportion of patients alive and progression free at 12 months from (APF12) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 3 years ]

APF12 is defined as the number (%) of patients who are alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of progression free survival at 12 months.
5. Proportion of patients alive and progression free at 18 months from(APF18) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 3 years ]

APF18 is defined as the number (%) of patients who are alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of progression free survival at 18 months.
6. Time to relapse (TTR) using the investigationsl site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 5 years ]

TTR is defined as the time from the date of randomisation until the first date of documented progression or death in the absence of disease progression.
7. Time to death or distant metastasis (TTDM) using investigational site assessments according to RECIST 1.1
[ Time Frame: Estimated to be up to 5 years ]

TTDM is defined as any new lesion that is outside of the radiaiton field.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age at least 18 years.
  2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
  3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
  4. World Health Organisation (WHO) Performance Status of 0 to 1.
  5. Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

  1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
  2. Active or prior autoimmune disease or history of immunodeficiency.
  3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
  5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
  6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Central Contact Backup: Cancer Study Locator
Telephone: 877 400 4656
Email: AstraZeneca@emergingmed.com
Study Officials: Marc Ballas, MD
Study Director
AstraZeneca
Locations: United States, Arizona
Research Site
[Recruiting]
Chandler, Arizona, United States
United States, Arkansas
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[Recruiting]
Fayetteville, Arkansas, United States
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[Recruiting]
Goodyear, Arkansas, United States
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[Recruiting]
Jonesboro, Arkansas, United States
United States, California
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[Recruiting]
Anaheim, California, United States
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[Recruiting]
La Mesa, California, United States
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[Not yet recruiting]
Los Angeles, California, United States
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Orange, California, United States
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Oxnard, California, United States
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[Recruiting]
Sacramento, California, United States
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Santa Rosa, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Connecticut
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[Recruiting]
Norwich, Connecticut, United States
United States, Florida
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Fleming Island, Florida, United States
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Fort Myers, Florida, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Port St Lucie, Florida, United States
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St. Petersburg, Florida, United States
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[Recruiting]
Tampa, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
United States, Illinois
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Decatur, Illinois, United States
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Evanston, Illinois, United States
United States, Iowa
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[Recruiting]
Waterloo, Iowa, United States
United States, Kansas
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[Recruiting]
Topeka, Kansas, United States
United States, Kentucky
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[Recruiting]
Hazard, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Salisbury, Maryland, United States
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Towson, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Michigan
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Lansing, Michigan, United States
United States, Minnesota
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Saint Louis Park, Minnesota, United States
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St Louis, Missouri, United States
United States, Nebraska
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Lincoln, Nebraska, United States
United States, New Jersey
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[Recruiting]
Hackensack, New Jersey, United States
United States, New York
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Lake Success, New York, United States
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[Withdrawn]
New York, New York, United States
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New York, New York, United States
United States, North Carolina
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Pinehurst, North Carolina, United States
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Winston-Salem, North Carolina, United States
United States, Ohio
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Middleton, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
United States, South Carolina
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Greensville, South Carolina, United States
United States, Tennessee
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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[Withdrawn]
Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
United States, Utah
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Salt Lake City, Utah, United States
United States, Virginia
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Fairfax, Virginia, United States
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Salem, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Washington, Washington, United States
Argentina
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[Withdrawn]
Bahia Blanca, Argentina
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[Withdrawn]
Berazategui, Argentina
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Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Cordoba, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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La Rioja, Argentina
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Pergamino, Argentina
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Pilar, Argentina
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Rosario, Argentina
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Viedma, Argentina
Australia
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Bedford Park, Australia
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Bendigo, Australia
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Box Hill, Australia
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Clayton, Australia
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Heidelberg, Australia
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Herston, Australia
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Kogarah, Australia
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Launceston, Australia
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Nedlands, Australia
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Port Macquarie, Australia
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Randwick, Australia
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Westmead, Australia
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Woolloongabba, Australia
Belgium
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Aalst, Belgium
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Gent, Belgium
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Gilly, Belgium
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Leuven, Belgium
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Libramont-Chevigny, Belgium
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Liège, Belgium
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Yvoir, Belgium
Brazil
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Barretos, Brazil
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Belo Horizonte, Brazil
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Brasília, Brazil
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Cachoeiro de Itapemirim, Brazil
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Fortaleza, Brazil
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Ijuí, Brazil
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Itajai, Brazil
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Juiz de Fora, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santa Cruz do Sul, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
Canada, Ontario
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Greenfield Park, Quebec, Canada
Canada, Saskatchewan
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Regina, Saskatchewan, Canada
Chile
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SAntiago, Chile
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Santiago, Chile
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Santiago, Chile
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Vina del Mar, Chile
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Viña del Mar, Chile
France
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Angers, France
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Avignon Cedex 9, France
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Bayonne, France
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Brest Cedex, France
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Creteil Cedex, France
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Dijon, France
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Lille cedex, France
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Lyon, France
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Marseille, France
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Montpellier Cedex, France
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Nantes, France
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Nice Cedex, France
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Pau Cedex, France
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Rennes, France
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Saint Herblain, France
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Toulouse, France
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Villejuif Cedex, France
Germany
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Berlin, Germany
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Coswig, Germany
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Goch, Germany
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Grosshansdorf, Germany
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Hamburg, Germany
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Hamburg, Germany
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Lubeck, Germany
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Löwenstein, Germany
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Recklinghausen, Germany
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Regensburg, Germany
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Trier, Germany
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Villingen-Schwenningen, Germany
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Worms, Germany
Greece
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Athens, Greece
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Crete, Greece
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Larissa, Greece
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Patra, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
Hungary
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Budapest, Hungary
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Budapest, Hungary
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Gyula, Hungary
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Miskolc, Hungary
Italy
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[Recruiting]
Aviano, Italy
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Benevento, Italy
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Catania, Italy
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Cremona, Italy
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Lecce, Italy
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Lucca, Italy
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Milano, Italy
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Milano, Italy
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Napoli, Italy
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Pisa, Italy
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Roma, Italy
Japan
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Bunkyo-ku, Japan
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Bunkyo-ku, Japan
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Chuo-ku, Japan
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Fukuoka, Japan
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Habikino-shi, Japan
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Hidaka-shi, Japan
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Hirakata-shi, Japan
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[Recruiting]
Hiroshima-shi, Japan
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Kanazawa, Japan
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Kashiwa-shi, Japan
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Kitaadachi-gun, Japan
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Kurume-shi, Japan
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Matsuyama-shi, Japan
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[Recruiting]
Nagoya-shi, Japan
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Natori-shi, Japan
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[Not yet recruiting]
Okayama-shi, Japan
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[Recruiting]
Osaka-shi, Japan
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[Recruiting]
Osakasayama-shi, Japan
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[Recruiting]
Ota-shi, Japan
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[Recruiting]
Sagamihara-shi, Japan
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Sakai-shi, Japan
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[Recruiting]
Sapporo-shi, Japan
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Sendai-shi, Japan
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Shinjuku-ku, Japan
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Sunto-gun, Japan
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Takatsuki-shi, Japan
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Ube-shi, Japan
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Yokohama-shi, Japan
Korea, Republic of
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Busan, Korea, Republic of
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Cheongju-si, Korea, Republic of
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Hwasun-gun, Korea, Republic of
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Incheon, Korea, Republic of
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Seongnam-si, Korea, Republic of
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[Recruiting]
Seoul, Korea, Republic of
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Suwon, Korea, Republic of
Mexico
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Cuautitlan Izcalli, Mexico
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El Salto, Mexico
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Guadalajara, Mexico
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Mexico, Mexico
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Monterrey, Mexico
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Oaxaca, Mexico
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Orizaba, Mexico
Netherlands
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Amsterdam, Netherlands
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Breda, Netherlands
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Eindhoven, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Tilburg, Netherlands
Peru
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Arequipa, Peru
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Cusco, Peru
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Lima, Peru
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Lima, Peru
Philippines
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Cagayan de Oro City, Philippines
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Cebu City, Philippines
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Manila, Philippines
Poland
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Gdańsk, Poland
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Lublin, Poland
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Poznan, Poland
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Warszawa, Poland
Russian Federation
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Obninsk, Russian Federation
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St. Petersburg, Russian Federation
Singapore
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Singapore, Singapore
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Singapore, Singapore
Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Kosice, Slovakia
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Nove Zamky, Slovakia
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Trnava, Slovakia
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Research Site
[Not yet recruiting]
Bloemfontein, South Africa
Research Site
[Recruiting]
Cape Town, South Africa
Research Site
[Not yet recruiting]
Durban, South Africa
Research Site
[Not yet recruiting]
Johannesburg, South Africa
Research Site
[Not yet recruiting]
Pretoria, South Africa
Research Site
[Not yet recruiting]
Vereeniging, South Africa
Spain
Research Site
[Not yet recruiting]
Alicante, Spain
Research Site
[Recruiting]
Barcelona, Spain
Research Site
[Not yet recruiting]
Barcelona, Spain
Research Site
[Not yet recruiting]
Gerona, Spain
Research Site
[Not yet recruiting]
Lleida, Spain
Research Site
[Recruiting]
Madrid, Spain
Research Site
[Not yet recruiting]
Madrid, Spain
Research Site
[Not yet recruiting]
San Sebastian, Spain
Research Site
[Recruiting]
Sevilla, Spain
Research Site
[Recruiting]
Valencia, Spain
Research Site
[Not yet recruiting]
Valencia, Spain
Research Site
[Not yet recruiting]
Zaragoza, Spain
Taiwan
Research Site
[Not yet recruiting]
Taichung, Taiwan
Research Site
[Recruiting]
Taipei, Taiwan
Research Site
[Not yet recruiting]
Taipei, Taiwan
Thailand
Research Site
[Withdrawn]
Bangkok, Thailand
Research Site
[Not yet recruiting]
Bangkok, Thailand
Research Site
[Not yet recruiting]
Muang, Thailand
Research Site
[Not yet recruiting]
Songkla, Thailand
Turkey
Research Site
[Not yet recruiting]
Adana, Turkey
Research Site
[Not yet recruiting]
Ankara, Turkey
Research Site
[Recruiting]
Istanbul, Turkey
Research Site
[Not yet recruiting]
Istanbul, Turkey
Research Site
[Not yet recruiting]
Izmir, Turkey
Research Site
[Not yet recruiting]
Konya, Turkey
Research Site
[Not yet recruiting]
Malatya, Turkey
United Kingdom
Research Site
[Withdrawn]
Coventry, United Kingdom
Research Site
[Not yet recruiting]
Glasgow, United Kingdom
Research Site
[Not yet recruiting]
London, United Kingdom
Research Site
[Not yet recruiting]
Manchester, United Kingdom
Research Site
[Not yet recruiting]
Truro, United Kingdom
Research Site
[Not yet recruiting]
Wolverhampton, United Kingdom
Vietnam
Research Site
[Not yet recruiting]
Hanoi, Vietnam
Research Site
[Recruiting]
Ho Chi Minh, Vietnam
Research Site
[Not yet recruiting]
Hue, Vietnam
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