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`History of Changesfor Study: NCT00637377
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`ES) v.s. National Library of Medicine
`ClinicalTrials.gov archive
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`History of Changes for Study: NCT00637377
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`VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW 2).
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`Latest version (submitted November 28, 2014) on ClinicalTrials.gov
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`e A study version is represented by a rowin the table.
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`e Select two study versions to compare. One each from columnsA and B.
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`e Chooseeither the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
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`e Click "Compare" to do the comparison and show thedifferences.
`
`e Select a version's Submitted Date link to see a rendering of the study for that version.
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`e The yellow A/B choicesin the table indicate the study versions currently compared below.A yellow table row indicates the study version currently being viewed.
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`e Hoverover the "Recruitment Status" to see howthestudy's recruitment status changed.
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`e Study edits or deletions are displayed in Fed.
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`e Study additions are displayed in green.
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`Study Record Versions
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`fvewion]AT©|Simao|e
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`March 17,2008 None (earliest Version on record)
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`April24,2008 Recruitment Status, Contacts/Locations, Study Status and Oversight
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`June 19,2008 Contacts/Locations and Study Status
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`Contacts/Locations, Study Status, Sponsor/Collaborators, Eligibility and Study Identification
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`October 2,2008
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`Contacts/Locations, Study Status and Study Identification
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`November4, 2008
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`Contacts/Locations, Study Status, Sponsor/Collaborators and Study Identification
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`December1.2008
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`January5, 2009
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`February5, 2009
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`April 2, 2009
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`June 4, 2009
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`July3, 2009
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`September 23,2009
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`Recruitment Status, Contacts/Locations and Study Status
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`November 19,2009
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`Study Status
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`February 19,2010
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`Contacts/Locations, Study Status, Armsand Interventions, Study Design and Study Identification
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`July92010
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`Contacts/Locations and Study Status
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`October 6, 2010
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`September12009Contacts/Locations, Study Status and Eligibility
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`November 30,2010 Contacts/Locations, Study Status and Study Design
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`February21,2011Study Status
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`November 28,2014 Study Status and References
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`May 23,2011 Study Status, Contacts/Locations, Sponsor/Collaborators and Study Identification
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`June 6,2011 Contacts/Locations, ArmsandInterventions, Study Status, Study Identification, Outcome Measures and
`Sponsor/Collaborators
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`December 16,2011 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Study Identification, Results,
`References, Contacts/Locations,Eligibility and Study Description
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`February 27,2012 Study Status
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`March12.2013 Reported Adverse Events, Contacts/Locations, Study Status and References
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`April 25.2014 Sponsor/Collaborators, Study Status, Baseline Characteristics and References
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`Study NCT00637377
`Submitted Date: March 17, 2008 (v1)
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`Study Identification
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`Unique Protocol ID: 91689
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`Brief Title: VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW 2).
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`Official Title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and
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`Tolerability of Repeated DosesofIntravitreal VEGF Trap in Subjects With Neovascular Age-related
`Macular Degeneration (AMD).
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`Secondary IDs: EurdaCT No.: 2007-000583-25
`311523
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`VIEW 2
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`Study Status
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`Record Verification: March 2008
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`Overall Status: Not yet recruiting
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`Study Start: March 2008
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`Primary Completion:
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`Study Completion: September 2011 [Anticipated]
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`First Submitted: March 12, 2008
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`First Submitted that March 17, 2008
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`Met QC Criteria:
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`First Posted: March 18, 2008 [Estimate]
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`Last Update Submitted that March 17, 2008
`Met QC Criteria:
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`Last Update Posted: March 18, 2008 [Estimate]
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`Sponsor/Collaborators
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`Sponsor: Bayer
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`Responsible Party:
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`Collaborators: Regeneron Pharmaceuticals
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`Oversight
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`U.S. FDA-regulated Drug:
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`U.S. FDA-regulated Device:
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`Data Monitoring:
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`Yes
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`Study Description
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`Brief Summary:
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`This study is a phaseIII, double-masked, randomized, study of the efficacy and safety of VEGF Trap-
`Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will
`be randomized in Europe, Asia, Japan, Australia and South America.
`
`Detailed Description:
`
`Conditions
`
`Conditions:
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`Macular Degeneration
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`Keywords:
`
`Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`Seniors
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`Neovascular Age-Related Macular Degeneration (AMD)
`Retinal Disease
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`Study Design
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`Study Type:
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`Interventional
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`Primary Purpose:
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`Treatment
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`Study Phase:
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`Phase 3
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`Interventional Study Model:
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`Parallel Assignment
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`4 Q
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`Numberof Arms:
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`Masking:
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`uadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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`Allocation:
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`Randomized
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`Enrollment:
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`1200 [Anticipated]
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`Armsand Interventions
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`Experimental: Arm 3
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`Experimental: Arm 1
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`Experimental: Arm 2
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`Active Comparator: Arm 4
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`every 4 weeks,but no less frequently than every 12 weeks.
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`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 8 weeks
`(including one additional 2,0 mg dose at Week4) during the
`first year. Thereafter a dose may be administered as
`frequently as every 4 weeks,but no less frequently than
`every 12 weeks.
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`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeksduring
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks,but no less frequently than
`every 12 weeks.
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`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks,but no less frequently than
`every 12 weeks.
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`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during thefirst year.
`Thereafter a dose may be administered as frequently as
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`Outcome Measures
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`Primary Outcome Measures:
`
`1. The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has
`lost fewer than 15 letters on the ETDRS chart compared to baseline (ie, prevention of moderate vision loss)
`Week52
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`Secondary Outcome Measures:
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`2. Mean change from baseline in BCVA as measured by ETDRSletter score at Week 52
`Week52
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`3. The proportion of subjects who gain at least 15 letters of vision at Week 52
`Week 52
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`4. Mean changefrom baseline in total NEI VFQ-25 score at Week 52
`Week 52
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`5. Mean change from baseline in CNV area at Week 52
`Week52
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`Eligibility
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`Minimum Age: 50 Years
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`Maximum Age:
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`Sex: All
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`Gender Based:
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`Accepts Healthy Volunteers: No
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`Criteria: Inclusion Criteria:
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`1. Signed informed consent.
`2. Men and women2 50 years of age.
`3. Active primary or recurrent subfoveal CNV lesions secondary to AMD,including juxtafoveal
`lesions that affect the fovea as evidenced by FAin the study eye.
`4. ETDRSbest-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye
`at 4 meters.
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`5. Willing, committed, and able to return for ALL clinic visits and complete all study-related
`procedures.
`6. Able to read,(or, if unable to read due to visual impairment, be read to verbatim by the person
`administering the informed consent or a family member) understand andwilling to sign the
`informed consent form.
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`Exclusion Criteria:
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`1. Any prior ocular(in the study eye) or systemic treatment or surgery for neovascular AMD, except
`dietary supplementsor vitamins.
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`2.
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`Anyprior or concomitant therapy with anotherinvestigational agent to treat neovascular AMD in
`the study eye.
`Anyprior treatment with anti-VEGF agentsin the study eye.
`. Total lesion size >12 disc areas (30.5 mm?, including blood, scars and neovascularization) as
`assessed by FAin the study eye.
`Subretinal hemorrhagesthat is either 50% or moreofthe total lesion area,or if the blood is under
`the fovea and is 1 or more disc areasin size in the study eye(if the blood is under the fovea,
`then the fovea must be surrounded by 270 degreesbyvisible CNV).
`. Scaror fibrosis making up >50% ofthe total lesion in the study eye.
`. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
`. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`. History of any vitreous hemorrhage within 4 weeksprior to Visit 1 in the study eye.
`. Presence of other causes of CNVin the study eye.
`. Prior vitrectomy in the study eye.
`12.
`History of retinal detachment or treatmentor surgery for retinal detachmentin the study eye.
`Any history of macular hole of stage 2 and abovein the study eye.
`Anyintraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid
`surgery, which may not have taken place within 1 month of Day 1, as long asit is unlikely to
`interfere with the injection.
`History orclinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular
`disease other than AMD in either eye.
`
`13.
`
`14.
`
`15.
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`Contacts/Locations
`
`Central Contact: BayerClinical Trials Contact
`Email: clinical-trials-contact@bayerhealthcare.com
`
`Central Contact Backup: Fortrial location information (Phone Menu Options\\
`Telephone: +1-888-84 22937
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`Study Officials: Study Director Bayer Study Manager
`Study Director
`Bayer
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`Locations: Argentina, Capital Federal
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`BuenosAires, Capital Federal, Argentina, C1015ABO
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`BuenosAires, Capital Federal, Argentina, C1023AAQ
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`BuenosAires, Capital Federal, Argentina, C1120AAN
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`BuenosAires, Capital Federal, Argentina, C1122AAI
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`Argentina, Cordoba
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`Cérdoba, Cérdoba, Argentina, X5000IIT
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`Argentina, Santa Fe
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`Rosario, Santa Fe, Argentina, 1288
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`Argentina
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`BuenosAires, Argentina, C1181ACH
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`Australia, New South Wales
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`Westmead, New South Wales, Australia, 2145
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`Australia, Victoria
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`East Melbourne, Victoria, Australia, 3002
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`Parkville, Victoria, Australia, 3050
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`Australia, Western Australia
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`Nedlands, Western Australia, Australia, 6009
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`Australia
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`Parramatta, Australia, 2150
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`Austria, Steiermark / 632
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`Graz, Steiermark / 632, Austria, 8036
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`Austria, Tirol / 632
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`Innsbruck, Tirol / 632, Austria, 6020
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`Austria
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`Linz, Austria, 4021
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`Salzburg, Austria, 5020
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`Wien, Austria, 1090
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`Belgium
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`Bruxelles, Belgium, 1070
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`Liege, Belgium, 4000
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`Brazil, Centro-oeste
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`Goiania, Centro-oeste, Brazil, 74210-010
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`Brazil, Parana
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`Londrina, Parana, Brazil, 86038440
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`Brazil, SP
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`Araraquara, SP, Brazil, 14801-310
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`Sao Paulo, SP, Brazil, 04023-900
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`Brazil
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`Belo Horizonte, Brazil, 30150-270
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`Sao Paulo, Brazil, 05651-901
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`Colombia
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`Bogota, Colombia
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`Cali, Colombia
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`Medellin, Colombia
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`Czech Republic
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`Brno, Czech Republic, 63400
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`Hradec Kralove, Czech Republic, 500 05
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`Olomouc, Czech Republic, 775 20
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`Praha 4, Czech Republic, 14000
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`France, Cedex 12
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`Paris, Cedex 12, France, 75557
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`France
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`Besancon, France, 25030
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`Bordeaux, France, 33000
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`Dijon Cedex, France, BP 1542-21
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`Grenoble, France, 38043
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`Lyon, France, 69003
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`Lyon, France, 69006
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`Marseille, France, 13008
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`Nantes Cedex, France, 44035
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`Paris, France, 75015
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`Germany, Baden-Wirttemberg / 274
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`Freiburg, Baden-Wirttemberg / 274, Germany, 79106
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`Germany, Baden-Wirttemberg / 275
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`Heidelberg, Baden-Wirttemberg / 275, Germany, 69112
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`Germany, Baden-Wirttemberg / 277
`
`Tubingen, Baden-Wirttemberg / 277, Germany, 72076
`
`Germany, Bayern / 280
`
`Erlangen, Bayern / 280, Germany, 91054
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`Munchen, Bayern / 280, Germany, 81675
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`Regensburg, Bayern / 280, Germany, 93053
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`Germany,Berlin / 285
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`Berlin, Berlin / 285, Germany, 12200
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`Germany, Hamburg / 287
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`Hamburg, Hamburg / 287, Germany, 20251
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`Germany, Nordrhein-Westfalen / 296
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`Dusseldorf, Nordrhein-Westfalen / 296, Germany, 40219
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`Germany, Nordrhein-Westfalen / 297
`
`K6ln, Nordrhein-Westfalen / 297, Germany, 50931
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`K6élIn, Nordrhein-Westfalen / 297, Germany, 50996
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`K6ln, Nordrhein-Westfalen / 297, Germany, 51109
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`Germany, Nordrhein-Westfalen / 298
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`Munster, Nordrhein-Westfalen / 298, Germany, 48145
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`Germany, Nordrhein-Westfalen / 320
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`Aachen, Nordrhein-Westfalen / 320, Germany, 52074
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`Germany, Nordrhein-Westfalen / 321
`
`Bonn, Nordrhein-Westfalen / 321, Germany, 53105
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`Germany, Nordrhein-Westfalen / 481
`
`Essen, Nordrhein-Westfalen / 481, Germany, 45147
`
`Germany, Nordrhein-Westfalen / 504
`
`Duisburg, Nordrhein-Westfalen / 504, Germany, 47119
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`Germany, Rheinland-Pfalz / 381
`
`Mainz, Rheinland-Pfalz / 381, Germany, 55131
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`Germany, Sachsen/ 313
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`Dresden, Sachsen / 313, Germany, 01307
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`Leipzig, Sachsen / 313, Germany, 04103
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`Germany, Schleswig-Holstein / 306
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`Kiel, Schleswig-Holstein / 306, Germany, 24105
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`Hungary
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`Budapest, Hungary, 1036
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`Budapest, Hungary, 1082
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`Budapest, Hungary, 1106
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`Veszprem, Hungary, 8200
`
`India, Tamil Nadu
`
`Chennai, Tamil Nadu, India, 600 006
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`Coimbatore, Tamil Nadu, India, 641014
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`Madurai, Tamil Nadu, India, 625 020
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`Pondicherry, Tamil Nadu, India, 600007
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`India
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`Bangalore, India, 560010
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`Chandigarh,India, 160062
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`Gujarat, India
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`Hyderabaad,India, 500 034
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`Kerala, India, 683572
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`Kolkata, India, 700073
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`Mumbai, India, 400031
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`NewDelhi, India, 110029
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`Orissa, India, 751 024
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`Israel
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`Afula, Israel, 18101
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`Jerusalem, Israel, 91120
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`PetachTikva, Israel, 49100
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`Rehovot, Israel, 76100
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`Tel Aviv, Israel, 64239
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`Tel Hashomer, Israel, 52621
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`Zerifin, Israel, 70300
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`Italy
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`Ancona,Italy, 60020
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`Bari, Italy, 70124
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`Catania, Italy
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`Firenze, Italy, 50139
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`Genova,Italy, 16132
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`Milano,Italy, 20132
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`Milano,Italy, 20142
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`Padova,Italy, 35128
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`Roma,Italy, 00133
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`Roma,Italy, 00168
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`Roma,Italy, 00198
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`Siena,Italy, 53100
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`Torino, Italy, 10126
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`Trieste, Italy, 34100
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`Udine,Italy, 33100
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`Varese, Italy, 21100
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`Japan,Aichi
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`Nagoya,Aichi, Japan, 466-8560
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`Nagoya,Aichi, Japan, 467-8602
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`Japan, Chiba
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`Urayasu, Chiba, Japan, 279-0021
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`Japan, Gunma
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`Maebashi, Gunma, Japan, 371-8511
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`Japan, Hokkaido
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`Sapporo, Hokkaido, Japan, 060-8604
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`Japan, Kagawa
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`Kida, Kagawa, Japan, 761-0793
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`Japan, Osaka
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`Hirakata, Osaka, Japan, 573-1191
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`Suita, Osaka, Japan, 565-0871
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`Japan, Shiga
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`Otsu, Shiga, Japan, 520-2192
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`Japan
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`Fukuoka, Japan, 812-8582
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`Fukushima, Japan, 960-1295
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`Kagoshima, Japan, 890-8520
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`Kyoto, Japan, 606-8507
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`Tokyo, Japan, 101-8309
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`Tokyo, Japan, 160-8582
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`Latvia
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`Riga, Latvia, 1002
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`Riga, Latvia, 1009
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`Riga, Latvia
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`Mexico, DF
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`Mexico City, DF, Mexico, 06800
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`Mexico City, DF, Mexico, 14080
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`Mexico, Estado de México
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`Metepec, Estado de México, Mexico, 52140
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`Mexico, Jalisco
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`Zapopan,Jalisco, Mexico, 45060
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`Mexico, Nuevo Leon
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`Monterrey, Nuevo Leon, Mexico, 64460
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`Mexico
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`Chihuahua, Mexico, 31238
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`Mexico City, Mexico, 06030
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`Mexico, D.F., Mexico, 04030
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`Netherlands, DD
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`Amsterdam, DD, Netherlands, 1100
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`Netherlands, EX
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`Nijmegen, EX, Netherlands, 6525
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`Netherlands, Noord Brabant
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`Eindhoven, Noord Brabant, Netherlands, 5623 EJ
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`Netherlands
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`Groningen, Netherlands, 9713 GZ
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`Leiden, Netherlands, 2333 ZA
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`Rotterdam, Netherlands, 3015 GD
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`Poland
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`Gdansk, Poland, 80-952
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`Katowice, Poland, 40-760
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`Poznan, Poland, 61-848
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`Warszawa, Poland, 00-416
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`Warszawa, Poland, 00-621
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`Warszawa, Poland, 01-755
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`Warszawa, Poland, 02-005
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`Warszawa, Poland, 03-709
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`Wroclaw, Poland, 50-368
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`Portugal
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`Coimbra, Portugal, 3000-548
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`Lisboa, Portugal, 1649-035
`
`Porto, Portugal, 4200- 319
`
`Slovakia
`
`Banska Bystrica, Slovakia, 97517
`
`Bratislava, Slovakia, 81369
`
`Martin, Slovakia, 03659
`
`Spain, Asturias
`
`Oviedo, Asturias, Spain, 33012
`
`Spain, La Coruna
`
`Santiago de Compostela, La Coruna, Spain, 15705
`
`Santiago de Compostela, La Coruna, Spain, 15706
`
`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
`
`17/20
`
`
`
`12/29/2020
`
`History of Changesfor Study: NCT00637377
`
`Spain, Madrid
`
`Aravaca, Madrid, Spain, 28023
`
`Spain
`
`Alicante, Spain, 03016
`
`Barcelona, Spain, 08017
`
`Barcelona, Spain, 08035
`
`Barcelona, Spain, 08036
`
`Madrid, Spain, 28002
`
`Madrid, Spain, 28040
`
`Madrid, Spain, 28046
`
`Malaga, Spain, 29010
`
`Pamplona, Spain, 31008
`
`Sevilla, Spain, 41013
`
`Sevilla, Spain, 41071
`
`Valencia, Spain, 46014
`
`Valencia, Spain, 46015
`
`Valladolid, Spain, 47005
`
`Sweden
`
`Jénkdéping, Sweden, 551 85
`
`Linképing, Sweden, 58185
`
`Lulea, Sweden, 97180
`
`Orebro, Sweden, 70185
`
`Stockholm, Sweden, 11282
`
`Switzerland, Basel / 633
`
`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
`
`18/20
`
`
`
`12/29/2020
`
`History of Changesfor Study: NCT00637377
`
`Basel, Basel / 633, Switzerland, 4031
`
`Switzerland, Genéve / 633
`
`Genéve, Genéve / 633, Switzerland, 1211
`
`Switzerland, Ziirich / 633
`
`Zurich, Zurich / 633, Switzerland, 8091
`
`Switzerland
`
`Bern, Switzerland, 3010
`
`United Kingdom, Greater London
`
`London, Greater London, United Kingdom, SE5 9RS
`
`United Kingdom, Hampshire
`
`Southampton, Hampshire, United Kingdom, SO16 6YD
`
`United Kingdom,NorthernIreland
`
`Belfast, Northern Ireland, United Kingdom, BT9 7BL
`
`United Kingdom,Scotland
`
`Edinburgh, Scotland, United Kingdom, EH3 9HA
`
`United Kingdom, Surrey
`
`Camberley, Surrey, United Kingdom, GU16 5UJ
`
`United Kingdom
`
`Aberdeen, United Kingdom, AB25 2ZN
`
`Birmingham, United Kingdom, B4 7ET
`
`Liverpool, United Kingdom, L7 8XP
`
`London, United Kingdom, EC1V 2PD
`
`London, United Kingdom, NW1 5QH
`
`Manchester, United Kingdom, M13 9PT
`
`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
`
`19/20
`
`
`
`12/29/2020
`
`History of Changesfor Study: NCT00637377
`
`Newcastle upon Tyne, United Kingdom, NE1 4LP
`
`Oxford, United Kingdom, OX3 9DU
`
`Plymouth, United Kingdom, PL6 8BX
`
`Torquay, United Kingdom, TQ2 7AA
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations:
`
`Links:
`
`Available IPD/Information:
`
`
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`Scroll up to access the controls
`
`Scroll to the Studytop
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`S_
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`National
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`Li
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`f Medicine
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`|
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`US.
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`National
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`Insti
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`|US.D
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`Servi
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`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
`
`20/20
`
`