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`History of Changes for Study: NCT00637377
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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).
`
`Latest version (submitted November 28, 2014) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either 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.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red.
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`Study additions are displayed in green .
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`Study Record Versions
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`A
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`March 17, 2008 None (earliest Version on record)
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`April 24, 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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`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
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`CELLTRION - EXHIBIT 1015
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`
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`History of Changes for Study: NCT00637377
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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).
`
`Latest version (submitted November 28, 2014) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either 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.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
`
`Study edits or deletions are displayed in red.
`
`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`A
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`B
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`Submitted Date
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`March 17, 2008 None (earliest Version on record)
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`April 24, 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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`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
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`August 4, 2008 Contacts/Locations, Study Status and Eligibility
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`September 30, 2008 Contacts/Locations, Study Status, Sponsor/Collaborators, Eligibility and Study Identification
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`October 2, 2008 Contacts/Locations, Study Status and Study Identification
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`November 4, 2008 Contacts/Locations, Study Status, Sponsor/Collaborators and Study Identification
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`December 1, 2008 Study Status and Contacts/Locations
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`January 5, 2009 Contacts/Locations and Study Status
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`February 5, 2009 Contacts/Locations and Study Status
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`March 5, 2009 Contacts/Locations, Study Status, Eligibility and Sponsor/Collaborators
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`April 2, 2009 Contacts/Locations, Study Status and Eligibility
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`May 4, 2009 Study Status
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`June 4, 2009 Contacts/Locations, Study Status and Eligibility
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`July 3, 2009 Contacts/Locations, Study Status and Eligibility
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`September 1, 2009 Contacts/Locations, Study Status and Eligibility
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`September 23, 2009 Recruitment Status, Contacts/Locations and Study Status
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`November 19, 2009 Study Status
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`February 19, 2010 Contacts/Locations, Study Status, Arms and Interventions, Study Design and Study Identification
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`July 9, 2010 Contacts/Locations and Study Status
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`October 6, 2010 Study Status
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`February 21, 2011 Study Status
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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, Arms and Interventions, 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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`March 12, 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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`November 28, 2014 Study Status and References
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`Compare
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` Comparison Format:
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`Scroll up to access the controls
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`Study NCT00637377
`Submitted Date: March 17, 2008 (v1)
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`Study Identification
`Unique Protocol ID: 91689
`Brief Title: VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW 2).
`Official Title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and
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`Study Status
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`History of Changes for Study: NCT00637377
`Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related
`Macular Degeneration (AMD).
`Secondary IDs: EurdaCT No.: 2007-000583-25
`311523
`VIEW 2
`
`Record Verification: March 2008
`Overall Status: Not yet recruiting
`Study Start: March 2008
`Primary Completion:
`Study Completion: September 2011 [Anticipated]
`
`First Submitted: March 12, 2008
`First Submitted that
`March 17, 2008
`Met QC Criteria:
`First Posted: March 18, 2008 [Estimate]
`
`March 17, 2008
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: March 18, 2008 [Estimate]
`Sponsor/Collaborators
`
`Sponsor: Bayer
`Responsible Party:
`Collaborators: Regeneron Pharmaceuticals
`
`Oversight
`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
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`Data Monitoring: Yes
`Study Description
`Brief Summary: This study is a phase III, 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: Macular Degeneration
`Keywords: Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`Seniors
`Neovascular Age-Related Macular Degeneration (AMD)
`Retinal Disease
`
`Study Design
`
`Study Type: Interventional
`Primary Purpose: Treatment
`Study Phase: Phase 3
`Interventional Study Model: Parallel Assignment
`Number of Arms: 4
`Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Allocation: Randomized
`Enrollment: 1200 [Anticipated]
`Arms and Interventions
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`Arms
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`Assigned Interventions
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`Experimental: Arm 3
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`Arms
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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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`History of Changes for Study: NCT00637377
`Assigned Interventions
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 8 weeks
`(including one additional 2,0 mg dose at Week 4) during the
`first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`
`Drug: VEGF Trap-Eye
`0.5 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.
`
`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.
`
`Drug: Ranibizumab
`0.5 mg 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.
`
`Outcome Measures
`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)
`Week 52
`Secondary Outcome Measures:
`2. Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52
`Week 52
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`3. The proportion of subjects who gain at least 15 letters of vision at Week 52
`Week 52
`4. Mean change from baseline in total NEI VFQ-25 score at Week 52
`Week 52
`5. Mean change from baseline in CNV area at Week 52
`Week 52
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`Eligibility
`
`Minimum Age: 50 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: Inclusion Criteria:
`
`1. Signed informed consent.
`2. Men and women ≥ 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 FA in the study eye.
`4. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye
`at 4 meters.
`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 and willing to sign the
`informed consent form.
`
`Exclusion Criteria:
`
`1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except
`dietary supplements or vitamins.
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`2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in
`the study eye.
`3. Any prior treatment with anti-VEGF agents in the study eye.
`4. Total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as
`assessed by FA in the study eye.
`5. Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under
`the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea,
`then the fovea must be surrounded by 270 degrees by visible CNV).
`6. Scar or fibrosis making up >50% of the total lesion in the study eye.
`7. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
`8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`10. Presence of other causes of CNV in the study eye.
`11. Prior vitrectomy in the study eye.
`12. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
`13. Any history of macular hole of stage 2 and above in the study eye.
`14. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid
`surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to
`interfere with the injection.
`15. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular
`disease other than AMD in either eye.
`
`Contacts/Locations
`Central Contact: Bayer Clinical Trials Contact
`Email: clinical-trials-contact@bayerhealthcare.com
`Central Contact Backup: For trial location information (Phone Menu Options \\
`Telephone: +1-888-84 22937
`Study Officials: Study Director Bayer Study Manager
`Study Director
`Bayer
`Locations: Argentina, Capital Federal
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`Buenos Aires, Capital Federal, Argentina, C1015ABO
`Buenos Aires, Capital Federal, Argentina, C1023AAQ
`Buenos Aires, Capital Federal, Argentina, C1120AAN
`Buenos Aires, Capital Federal, Argentina, C1122AAI
`Argentina, Córdoba
`Córdoba, Córdoba, Argentina, X5000IIT
`Argentina, Santa Fe
`Rosario, Santa Fe, Argentina, 1288
`Argentina
`Buenos Aires, Argentina, C1181ACH
`Australia, New South Wales
`Westmead, New South Wales, Australia, 2145
`Australia, Victoria
`East Melbourne, Victoria, Australia, 3002
`Parkville, Victoria, Australia, 3050
`Australia, Western Australia
`Nedlands, Western Australia, Australia, 6009
`Australia
`Parramatta, Australia, 2150
`Austria, Steiermark / 632
`Graz, Steiermark / 632, Austria, 8036
`Austria, Tirol / 632
`Innsbruck, Tirol / 632, Austria, 6020
`Austria
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`Linz, Austria, 4021
`Salzburg, Austria, 5020
`Wien, Austria, 1090
`Belgium
`Bruxelles, Belgium, 1070
`Liege, Belgium, 4000
`Brazil, Centro-oeste
`Goiania, Centro-oeste, Brazil, 74210-010
`Brazil, Paraná
`Londrina, Paraná, Brazil, 86038440
`Brazil, SP
`Araraquara, SP, Brazil, 14801-310
`Sao Paulo, SP, Brazil, 04023-900
`Brazil
`Belo Horizonte, Brazil, 30150-270
`Sao Paulo, Brazil, 05651-901
`Colombia
`Bogota, Colombia
`Cali, Colombia
`Medellín, Colombia
`Czech Republic
`Brno, Czech Republic, 63400
`Hradec Kralove, Czech Republic, 500 05
`Olomouc, Czech Republic, 775 20
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`Praha 4, Czech Republic, 14000
`France, Cedex 12
`Paris, Cedex 12, France, 75557
`France
`Besancon, France, 25030
`Bordeaux, France, 33000
`Dijon Cedex, France, BP 1542-21
`Grenoble, France, 38043
`Lyon, France, 69003
`Lyon, France, 69006
`Marseille, France, 13008
`Nantes Cedex, France, 44035
`Paris, France, 75015
`Germany, Baden-Württemberg / 274
`Freiburg, Baden-Württemberg / 274, Germany, 79106
`Germany, Baden-Württemberg / 275
`Heidelberg, Baden-Württemberg / 275, Germany, 69112
`Germany, Baden-Württemberg / 277
`Tübingen, Baden-Württemberg / 277, Germany, 72076
`Germany, Bayern / 280
`Erlangen, Bayern / 280, Germany, 91054
`München, Bayern / 280, Germany, 81675
`Regensburg, Bayern / 280, Germany, 93053
`Germany, Berlin / 285
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`Berlin, Berlin / 285, Germany, 12200
`Germany, Hamburg / 287
`Hamburg, Hamburg / 287, Germany, 20251
`Germany, Nordrhein-Westfalen / 296
`Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40219
`Germany, Nordrhein-Westfalen / 297
`Köln, Nordrhein-Westfalen / 297, Germany, 50931
`Köln, Nordrhein-Westfalen / 297, Germany, 50996
`Köln, Nordrhein-Westfalen / 297, Germany, 51109
`Germany, Nordrhein-Westfalen / 298
`Münster, Nordrhein-Westfalen / 298, Germany, 48145
`Germany, Nordrhein-Westfalen / 320
`Aachen, Nordrhein-Westfalen / 320, Germany, 52074
`Germany, Nordrhein-Westfalen / 321
`Bonn, Nordrhein-Westfalen / 321, Germany, 53105
`Germany, Nordrhein-Westfalen / 481
`Essen, Nordrhein-Westfalen / 481, Germany, 45147
`Germany, Nordrhein-Westfalen / 504
`Duisburg, Nordrhein-Westfalen / 504, Germany, 47119
`Germany, Rheinland-Pfalz / 381
`Mainz, Rheinland-Pfalz / 381, Germany, 55131
`Germany, Sachsen / 313
`Dresden, Sachsen / 313, Germany, 01307
`Leipzig, Sachsen / 313, Germany, 04103
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`Germany, Schleswig-Holstein / 306
`Kiel, Schleswig-Holstein / 306, Germany, 24105
`Hungary
`Budapest, Hungary, 1036
`Budapest, Hungary, 1082
`Budapest, Hungary, 1106
`Veszprem, Hungary, 8200
`India, Tamil Nadu
`Chennai, Tamil Nadu, India, 600 006
`Coimbatore, Tamil Nadu, India, 641014
`Madurai, Tamil Nadu, India, 625 020
`Pondicherry, Tamil Nadu, India, 600007
`India
`Bangalore, India, 560010
`Chandigarh, India, 160062
`Gujarat, India
`Hyderabaad, India, 500 034
`Kerala, India, 683572
`Kolkata, India, 700073
`Mumbai, India, 400031
`New Delhi, India, 110029
`Orissa, India, 751 024
`Israel
`Afula, Israel, 18101
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`Jerusalem, Israel, 91120
`Petach Tikva, Israel, 49100
`Rehovot, Israel, 76100
`Tel Aviv, Israel, 64239
`Tel Hashomer, Israel, 52621
`Zerifin, Israel, 70300
`Italy
`Ancona, Italy, 60020
`Bari, Italy, 70124
`Catania, Italy
`Firenze, Italy, 50139
`Genova, Italy, 16132
`Milano, Italy, 20132
`Milano, Italy, 20142
`Padova, Italy, 35128
`Roma, Italy, 00133
`Roma, Italy, 00168
`Roma, Italy, 00198
`Siena, Italy, 53100
`Torino, Italy, 10126
`Trieste, Italy, 34100
`Udine, Italy, 33100
`Varese, Italy, 21100
`Japan, Aichi
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`Nagoya, Aichi, Japan, 466-8560
`Nagoya, Aichi, Japan, 467-8602
`Japan, Chiba
`Urayasu, Chiba, Japan, 279-0021
`Japan, Gunma
`Maebashi, Gunma, Japan, 371-8511
`Japan, Hokkaido
`Sapporo, Hokkaido, Japan, 060-8604
`Japan, Kagawa
`Kida, Kagawa, Japan, 761-0793
`Japan, Osaka
`Hirakata, Osaka, Japan, 573-1191
`Suita, Osaka, Japan, 565-0871
`Japan, Shiga
`Otsu, Shiga, Japan, 520-2192
`Japan
`Fukuoka, Japan, 812-8582
`Fukushima, Japan, 960-1295
`Kagoshima, Japan, 890-8520
`Kyoto, Japan, 606-8507
`Tokyo, Japan, 101-8309
`Tokyo, Japan, 160-8582
`Latvia
`Riga, Latvia, 1002
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`Riga, Latvia, 1009
`Riga, Latvia
`Mexico, DF
`Mexico City, DF, Mexico, 06800
`Mexico City, DF, Mexico, 14080
`Mexico, Estado de México
`Metepec, Estado de México, Mexico, 52140
`Mexico, Jalisco
`Zapopan, Jalisco, Mexico, 45060
`Mexico, Nuevo Leon
`Monterrey, Nuevo Leon, Mexico, 64460
`Mexico
`Chihuahua, Mexico, 31238
`Mexico City, Mexico, 06030
`Mexico, D.F., Mexico, 04030
`Netherlands, DD
`Amsterdam, DD, Netherlands, 1100
`Netherlands, EX
`Nijmegen, EX, Netherlands, 6525
`Netherlands, Noord Brabant
`Eindhoven, Noord Brabant, Netherlands, 5623 EJ
`Netherlands
`Groningen, Netherlands, 9713 GZ
`Leiden, Netherlands, 2333 ZA
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`Rotterdam, Netherlands, 3015 GD
`Poland
`Gdansk, Poland, 80-952
`Katowice, Poland, 40-760
`Poznan, Poland, 61-848
`Warszawa, Poland, 00-416
`Warszawa, Poland, 00-621
`Warszawa, Poland, 01-755
`Warszawa, Poland, 02-005
`Warszawa, Poland, 03-709
`Wroclaw, Poland, 50-368
`Portugal
`Coimbra, Portugal, 3000-548
`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
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`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
`Jönköping, Sweden, 551 85
`Linköping, Sweden, 58185
`Luleå, Sweden, 97180
`Örebro, Sweden, 70185
`Stockholm, Sweden, 11282
`Switzerland, Basel / 633
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`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
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`18/20
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`
`
`12/29/2020
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`History of Changes for Study: NCT00637377
`Basel, Basel / 633, Switzerland, 4031
`Switzerland, Genève / 633
`Genève, Genève / 633, Switzerland, 1211
`Switzerland, Zürich / 633
`Zürich, Zürich / 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, Northern Ireland
`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
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`
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`12/29/2020
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`History of Changes for 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:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged#StudyPageTop
`
`20/20
`
`
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