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`History of Changes for Study: NCT00101634
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`US. National Library of Medicine
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`ClinicalTria/s.g0v archive
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`History of Changes for Study: NCT00101634
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`Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects With Schizophrenia
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`Latest version (submitted June 6, 2011) on CIinigalTrials.go_v
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`A study version is represented by a row in the table.
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`Select two study versions to compare. One each from columns A and B.
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`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.
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`Click "Compare" to do the comparison and show the differences.
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`Select a version's Submitted Date link to see a rendering of the study for that version.
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`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.
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`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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`June 23,2_005
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`None (earliest Version on record)
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`Contacts/Locations, Study Design and Study Status
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`SEWJM
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`Contacts/Locations and Study Status
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`Noyember 23, 2Q05
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`Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study
`Design
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`Recruitment Status, Study Status and Contacts/Locations
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`Study Status and Study Identification
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`Study Status
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`Ecumenism
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`Study Status, Contacts/Locations. Outcome Measures, Study Description, Study
`Identification, Eligibility, Arms and Interventions, Study Design, Conditions and
`Oversight
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`Study Design, Study Status, References, Contacts/Locations, Eligibility and Study
`Description
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`Study Status
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`April 26. 201 Q
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`w1m Study Status and Study Design
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`“My56?}? §n§‘§‘e”fi (1PR202000440) bx 1033, p. 001
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`History of Changes for Study: NCT00101634
`1/30/2020
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`Side-by—Side
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`Scroll up to access the mntrols
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`Study NCT00101634
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`Submitted Date: September 21, 2005 (v3)
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`Study Identification
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`Unique Protocol ID: R092670-PSY-3004
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`Brief Title: Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects \Mth
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`Schizophrenia
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`Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response
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`Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and
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`100 mg eq) of Paliperidone Palmitate in Subjects With Schizophrenia
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`Secondary IDs:
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`Study Status
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`Record Verification: September 2005
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`Overall Status: Recruiting
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`Study Start:
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`Primary Completion:
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`Study Completion:
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`First Submitted: January 12, 2005
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`First Submitted that January 12, 2005
`Met QC Criteria:
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`First Posted: January 13, 2005 [Estimate]
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`Last Update Submitted that September 21, 2005
`Met QC Criteria:
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`Last Update Posted: September 23, 2005 [Estimate]
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`Sponsor/Collaborators
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`Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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`Responsible Party:
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`Collaborators:
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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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`Study Description
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`Brief Summary: This study is to determine the efficacy (how well the drug works), safety, and side
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 002
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`History of Changes for Study: NCT00101634
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`effects of the study medication compared to placebo in the treatment of the symptoms
`of schizophrenia in adults.
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`Detailed Description:
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`Conditions
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`Study Design
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`Conditions:
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`Schizophrenia
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`Keywords:
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`Schizophrenia
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`psychosis
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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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`Number of Arms:
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`Masking:
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`Double (masked roles unspecified)
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`Allocation:
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`Randomized
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`Enrollment:
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`Arms and interventions
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`intervention Details:
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`Drug: R092670/Placebo
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`Outcome Measures
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`Eligibility
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`Minimum Age:
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`18 Years
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`Maximum Age:
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`Sex:
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`All
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`Gender Based:
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`Accepts Healthy Volunteers:
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`NO
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`Criteria:
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`Inclusion Criteria:
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`0 Adults aged 18 years and older
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`- Met diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year
`before screening
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`0 Body mass index (BMl) of >15.0 kg/mz
`. Women of childbearing potential must have a negative urine pregnancy before
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`receiving a dose of study drug
`. Must be healthy based on medical exam, laboratory tests, and
`electrocardiogram
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`Exclusion Criteria:
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`c Subjects who are unable to provide their own consent or who have been
`involuntarily committed to psychiatric hospitalization
`- Acute or unstable medical conditions
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1033, p. 003
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`History of Changes for Study: NCT00101634
`. Significant risk of suicidal, homicidal or violent ideation or behavior as clinically
`assessed by the investigator
`0 Woman who is pregnant, breast-feeding, or planning to become pregnant during
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`the study period
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`. Primary active DSM—IV Axis I diagnosis other than schizophrenia
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`ContactsILocations
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`Locations: United States, California
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`[Recruiting]
`Cerritos, California, United States, 90814
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`Contact: Study Contact 562—402-3102
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`[Recruiting]
`La Mesa, California, United States, 91942
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`Contact: Study Contact 619-667-4568
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`[Recruiting]
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`Los Angeles, California, United States, 90011
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`Contact: Study Contact 714-224-8262
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`[Recruiting]
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`Oceanside, California, United States, 92056
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`Contact: Study Contact 760-631-3056
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`[Recruiting]
`San Marino, California, United States, 91108
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`Contact: Study Contact 6264058808
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`[Recruiting]
`Santa Ana, California, United States, 92705
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`Contact: Study Contact 714-547-4100
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`United States, District of Columbia
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`[Recruiting]
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`Washington, District of Columbia, United States, 20016
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`Contact: Study Contact 202-885-5666
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`United States, Florida
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`[Recruiting]
`Jacksonville, Florida, United States, 32256
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`Contact: Study Contact 904-673-2998
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`[Recruiting]
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`Leesburg, Florida, United States, 34748
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`Contact: Study Conact 352-315-7817
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`[Recruiting]
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`South Miami, Florida, United States, 33143
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`Contact: Study Contact 305-669-6166
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`United States, Georgia
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`[Recruiting]
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`Atlanta, Georgia, United States, 30308
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`Contact: Study Contact 404-881-5800
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`[Recruiting]
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`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 004
`httpszllclinicaltrials.gov/ct2/history/NCT00101634?V_3=View#StudyPageTop
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`Augusta, Georgia, United States, 30912
`Contact: Study Contact 706-721 -7968
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`United States, Illinois
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`[Recruiting]
`Oak Brook, Illinois, United States, 60523
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`Contact: Study Contact 6309281000
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`United States, Louisiana
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`[Recruiting]
`Shreveport, Louisiana, United States, 71101
`Contact: Study Contact 318-227-9600
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`United States, New Jersey
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`[Recruiting]
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`Kenilworth, New Jersey, United States, 07033
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`Contact: Study Contact 908-241-1022
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`United States, New Mexico
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`[Recruiting]
`Albuquerque, New Mexico, United States, 87111
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`Contact: Study Contact 505-848-3773
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`United States, New York
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`[Recruiting]
`Lawrence, New York, United States, 11559
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`Contact: Study Contact 516-295-7230
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`United States, Ohio
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`[Recruiting]
`Cincinnati, Ohio, United States, 45267-0559
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`Contact: Study Contact 513-558-4615
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`United States, Oklahoma
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`[Terminated]
`Oklahoma City, Oklahoma, United States, 73118
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`United States, Texas
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`[Recruiting]
`Desoto, Texas, United States, 75115
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`Contact: Study Contact 972-283-6242
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`United States, Virginia
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`[Recruiting]
`Falls Church, Virginia, United States, 22044
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`Contact: Study Contact 7035316179
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`United States, Wisconsin
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`[Recruiting]
`Milwaukee, Vlfisconsin, United States, 53295
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`Contact: Study Contact 4143842000
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`Bulgaria
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`[Recruiting]
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`Mylan v. Janssen (IPR2020-00440) EX. 1033, p. 005
`https://clinicaltria|s.gov/ct2/history/NCT00101634?V_3=View#StudyPageTop
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`Burgas, Bulgaria, 8000
`Contact: Study Contact 35956812350
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`[Recruiting]
`Radnevo, Bulgaria, 6260
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`Contact: Study Contact 3592981782586
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`[Recruiting]
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`Sofia, Bulgaria, 1000
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`Contact: Study Contact 35929816061
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`Mexico, 64960
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`[Not yet recruiting]
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`Monterrey, 64960, Mexico
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`Contact: Study Contact 518111995510
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`Mexico
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`[Not yet recruiting]
`Monterrey, Mexico, 64960
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`Contact: Study Contact 528183523051
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`[Not yet recruiting]
`Puebla, Mexico, 72573
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`Contact: Study Contact 522222161540
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`[Not yet recruiting]
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`Tampico, Mexico, 89130
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`Contact: Study Contact 528332131862
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`Romania
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`[Recruiting]
`Brasov, Romania, 500124
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`Contact: Study Contact 40726112087
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`[Recruiting]
`Bucuresti, Romania, 041914
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`Contact: Study Contact 40726112087
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`[Recruiting]
`Jud TIMIS, Romania, 307235
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`Contact: Study Contact 40256394442
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`[Recruiting]
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`Tg. MURES, Romania, 540139
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`Contact: Study Contact 40744512724
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`Russian Federation
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`[Recruiting]
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`Kazan, Russian Federation, 420012
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`Contact: Study Contact 78432360942
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`[Recruiting]
`Lenigradsky Region, Russian Federation, 188357
`Contact: Study Contact 78127156441
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`[Recruiting]
`Moscow, Russian Federation, 113152
`Contact: Study Contact 70959528331
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 006
`httpszllclinicaltrials.govlct2/history/NCTOO101634?V_3=\fiew#StudyPageTop
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`History of Changes for Study: NCT00101634
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`[Recruiting]
`Moscow, Russian Federation, 115522
`Contact: Study Contact 70951165183
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`[Recruiting]
`Nizny Novgorod, Russian Federation, 603155
`Contact: Study Contact 78312192496
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`[Recruiting]
`Saratov, Russian Federation, 410028
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`Contact: Study Contact 78452224905
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`[Recruiting]
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`St Petersburg, Russian Federation, 193019
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`Contact: Study Contact 78125677217
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`[Recruiting]
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`St Petersburg, Russian Federation, 78123018567
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`Contact: Study Contact 78123018567
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`South Africa
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`[Not yet recruiting]
`Bellville, South Africa, 7530
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`Contact: Study Contact 4210219404463
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`[Recruiting]
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`Centurion, South Africa
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`Contact: Study Contact 4210126640222
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`[Not yet recruiting]
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`Eastern Cape, South Africa, 5100
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`Contact: Study Contact 4210475022233
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`[Recruiting]
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`Johannesburg, South Africa
`Contact: Study Contact 4210125214143
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`lPDSharing
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`References
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`Plan to Share IPD:
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`Citations:
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`Links:
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`Available lPD/lnformation:
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`WWW
`WW
`
`I [1.8. National Institutes of Health lmnmmmueafllmanmbes
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`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 007
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