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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03814785
Registration number
NCT03814785
Ethics application status
Date submitted
17/08/2011
Date registered
18/08/2011
Titles & IDs
Public title
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
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Scientific title
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma
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Secondary ID [1]
0
0
2010-019522-13
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Secondary ID [2]
0
0
GP13-301
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Universal Trial Number (UTN)
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Trial acronym
ASSIST_FL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
0
0
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Arthritis, Psoriatic
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Neurological
0
0
0
0
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Alzheimer's disease
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Neurological
0
0
0
0
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - GP2013
Treatment: Other - rituximab
Treatment: Drugs - Placebo
Treatment: Drugs - Ustekinumab 45 mg
Treatment: Drugs - Ustekinumab 90 mg
Experimental: GP2013 - Type: Biological/Vaccine
Active comparator: rituximab - Type: Biological/Vaccine
Experimental: Placebo - Participants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.
Experimental: Ustekinumab 45 mg - Participants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Experimental: Ustekinumab 90 mg - Participants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Treatment: Other: GP2013
Type: Biological/Vaccine
Treatment: Other: rituximab
Type: Biological/Vaccine
Treatment: Drugs: Placebo
SC injections
Treatment: Drugs: Ustekinumab 45 mg
SC injections
Treatment: Drugs: Ustekinumab 90 mg
SC injections
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
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Timepoint [1]
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24 weeks
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Primary outcome [2]
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Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
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Assessment method [2]
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An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters \[cm\]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
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Timepoint [2]
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0
Week 24
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Secondary outcome [1]
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0
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
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Assessment method [1]
0
0
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Timepoint [1]
0
0
24 weeks
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Secondary outcome [2]
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0
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
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Assessment method [2]
0
0
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Timepoint [2]
0
0
24 weeks
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Secondary outcome [3]
0
0
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
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Assessment method [3]
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Number of participants with progression free survival events
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Timepoint [3]
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0
3 years
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Secondary outcome [4]
0
0
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
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Assessment method [4]
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0
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
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Timepoint [4]
0
0
3 years
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Secondary outcome [5]
0
0
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
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Assessment method [5]
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0
number of participants with confirmed positive ADA
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Timepoint [5]
0
0
24 weeks, 3 years
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Secondary outcome [6]
0
0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
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Assessment method [6]
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C max
For descriptive purposes only, no hypothesis testing
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Timepoint [6]
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0
day 63
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Secondary outcome [7]
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To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
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Assessment method [7]
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C through
For descriptive purposes only, no hypothesis testing
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Timepoint [7]
0
0
day 63
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Secondary outcome [8]
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0
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
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Assessment method [8]
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AUEC (0-21d)
For descriptive purposes only, no hypothesis testing
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Timepoint [8]
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21 days
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Secondary outcome [9]
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Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
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Assessment method [9]
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The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.
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Timepoint [9]
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0
Day 1 (Baseline) and Week 24
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Secondary outcome [10]
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Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
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Assessment method [10]
0
0
The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.
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Timepoint [10]
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0
Week 24
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Secondary outcome [11]
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Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
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Assessment method [11]
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An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
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Timepoint [11]
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Week 24
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Secondary outcome [12]
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Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
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Assessment method [12]
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An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
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Timepoint [12]
0
0
Week 24
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Secondary outcome [13]
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0
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
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Assessment method [13]
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The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFa) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.
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Timepoint [13]
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Day 1 (Baseline) and Week 24
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Eligibility
Key inclusion criteria
* Patient with previously untreated advanced stage, CD20-positive FL
* Patient with ECOG performance status 0, 1 or 2.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
* Patient who has previously received any prior therapy for lymphoma
* Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
* Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/01/2018
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Sample size
Target
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Accrual to date
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Final
629
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Investigative site - Adelaide
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Recruitment hospital [2]
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Investigative site - Ballarat
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Recruitment hospital [3]
0
0
Investigative site - Epping
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Recruitment hospital [4]
0
0
Investigative site - Footscray
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Recruitment hospital [5]
0
0
Investigative site - Wodonga
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Recruitment hospital [6]
0
0
- Camperdown
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Recruitment hospital [7]
0
0
- Heidelberg
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Recruitment hospital [8]
0
0
- Maroochydore
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Recruitment hospital [9]
0
0
- Melbourne
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Recruitment hospital [10]
0
0
- Perth
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Recruitment hospital [11]
0
0
- Woodville
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Recruitment postcode(s) [1]
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0
- Adelaide
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Recruitment postcode(s) [2]
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0
- Ballarat
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Recruitment postcode(s) [3]
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0
- Epping
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Recruitment postcode(s) [4]
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0
- Footscray
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Recruitment postcode(s) [5]
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0
- Wodonga
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Recruitment postcode(s) [6]
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0
- Camperdown
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Recruitment postcode(s) [7]
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0
- Heidelberg
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Recruitment postcode(s) [8]
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0
- Maroochydore
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Recruitment postcode(s) [9]
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0
- Melbourne
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Recruitment postcode(s) [10]
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0
- Perth
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Recruitment postcode(s) [11]
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0
- Woodville
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Recruitment outside Australia
Country [1]
0
0
Japan
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State/province [1]
0
0
Nagasaki
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Country [2]
0
0
Argentina
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State/province [2]
0
0
La Plata
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0
0
Argentina
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State/province [3]
0
0
Rosario
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0
0
Argentina
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State/province [4]
0
0
San Miguel de Tucuman
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Country [5]
0
0
Austria
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State/province [5]
0
0
Graz
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Country [6]
0
0
Austria
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State/province [6]
0
0
Wien
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Country [7]
0
0
Brazil
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State/province [7]
0
0
Barretos
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0
0
Brazil
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State/province [8]
0
0
Botucatu
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0
0
Brazil
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0
0
Campinas
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0
0
Brazil
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0
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Curitiba
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0
0
Brazil
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State/province [11]
0
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Florianopolis
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0
0
Brazil
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0
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Fortaleza
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0
0
Brazil
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0
0
Goiania
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0
0
Brazil
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0
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Jau
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0
0
Brazil
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State/province [15]
0
0
Passo Fundo
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Country [16]
0
0
Brazil
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State/province [16]
0
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Porto Alegre
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0
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Brazil
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State/province [17]
0
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Rio de Janeiro
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0
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Brazil
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Santo Andre
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0
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Brazil
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Sao Paulo
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0
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Brazil
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State/province [20]
0
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Sorocaba
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0
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Bulgaria
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0
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Pleven
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0
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Bulgaria
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0
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Plovdiv
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0
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Bulgaria
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0
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Ruse
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0
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Bulgaria
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0
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Sofia
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0
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Bulgaria
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Varna
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0
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Colombia
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Medellin
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Colombia
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Monteria
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France
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Colmar
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France
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Nimes
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0
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France
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Strasbourg
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0
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Germany
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Bad Saarow
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0
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Germany
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0
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Koblenz
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0
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Greece
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Athens
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Greece
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Ioannina
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0
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Greece
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Larissa
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Greece
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Patras
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0
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Hungary
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Györ
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Hungary
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Kaposvar
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0
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India
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Ahmedabad
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India
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Amritsar
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0
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India
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Aurangabad
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0
0
India
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0
0
Bangalore
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0
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India
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0
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Chennai
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0
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India
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Hyderabad
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0
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India
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Kolkata
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0
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India
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Madurai
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0
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India
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0
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Mumbai
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0
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India
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0
0
Nashik
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0
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India
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New Delhi
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0
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India
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Pune
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0
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India
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Surat
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India
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Trivandrum
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India
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Vellore
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Ireland
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Dublin
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Ireland
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Limerick
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0
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Ireland
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Waterford
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0
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Israel
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0
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Ashkelon
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0
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Israel
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0
0
Nahariya
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0
0
Italy
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0
0
Bari
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0
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Italy
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0
0
Firenze
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0
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Italy
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0
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Meldola
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0
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Italy
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Milano
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Italy
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Palermo
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Italy
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Pavia
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0
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Italy
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Pescara
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0
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Italy
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Piacenza
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0
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Italy
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Ravenna
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0
0
Italy
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State/province [68]
0
0
Reggio Calabria
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Country [69]
0
0
Italy
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State/province [69]
0
0
Varese
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0
0
Japan
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0
0
Aomori
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0
0
Japan
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0
0
Fukuoka
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0
0
Japan
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0
0
Gifu
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0
0
Japan
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State/province [73]
0
0
Kagoshima
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0
0
Japan
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0
0
Kitakyushu
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0
0
Japan
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0
0
Kobe
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0
0
Japan
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0
0
Komaki
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0
0
Japan
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0
0
Matsuyama
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0
0
Japan
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0
0
Ogaki
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Country [79]
0
0
Japan
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State/province [79]
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Okayama
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Japan
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Omura
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Japan
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Saga
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Japan
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Tachikawa
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Japan
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Otake
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Malaysia
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Alor Setar
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Malaysia
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Ampang
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Malaysia
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George Town
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Malaysia
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Ipoh
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Malaysia
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Johor Bahru
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Malaysia
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Klang
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Melaka
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Malaysia
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Pulau Pinang
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Malaysia
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Subang Jaya
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Netherlands
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Amsterdam
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Netherlands
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Delft
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Netherlands
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Gouda
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Netherlands
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Heerlen
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Netherlands
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Rotterdam
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Netherlands
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Schiedam
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Netherlands
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Sittard
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Netherlands
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Zwolle
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Peru
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Lima
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Brzozow
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Bydgoszcz
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Chorzow
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Krakow
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Lublin
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Warszawa
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Krasnodar
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Rostov-on -Don
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Russian Federation
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St. Petersburg
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Cape Town
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South Africa
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George
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South Africa
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Johannesburg
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Port Elizabeth
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South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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San Sebastian
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Spain
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Sevilla
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Spain
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Zaragoza
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Eastbourne
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United Kingdom
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London
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United Kingdom
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Worthing
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Japan
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Shizuoka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Coahuila
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Mexico
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Aguascalientes
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Auckland
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New Zealand
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Hamilton
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Poland
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Poznan
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Poland
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Wroclaw
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Romania
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Dolj
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Romania
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Timis
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Romania
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Bucuresti
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Russian Federation
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Gatchina district, Leningrad region
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Russian Federation
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Kazan
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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Yaroslavl
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Western Cape
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Florida
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Illinois
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Indiana
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Missouri
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Nebraska
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Washington
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Austria
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Innsbruck
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Austria
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Wien N/A
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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Finland
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Hyvinkää
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Kiel
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Germany
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Mahlow
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Germany
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Mainz
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Germany
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Regensburg
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Germany
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Tübingen
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Hungary
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Budapest N/A
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemét
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Hungary
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Szeged
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Hungary
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Szolnok
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Hungary
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Veszprém
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Latvia
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Riga
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Siauliai
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New Zealand
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Christchurch
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New Zealand
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Rotorua
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New Zealand
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Wellington
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Poland
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Bialystok
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Poland
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Elblag
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Poland
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Torun
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Russian Federation
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Ekaterinburg
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Russian Federation
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Korolev
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sandoz
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Address
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Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Novartis Pharmaceuticals
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03814785
Query!
Trial related presentations / publications
Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.
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Public notes
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Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03814785