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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05624450
Registration number
NCT05624450
Ethics application status
Date submitted
11/11/2022
Date registered
22/11/2022
Titles & IDs
Public title
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
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Scientific title
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
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Secondary ID [1]
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0
2022-003107-15
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Secondary ID [2]
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D9185C00001
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Universal Trial Number (UTN)
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Trial acronym
TILIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Viral Lung Infection and Acute Respiratory Failure
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0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Sexually transmitted infections
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tozorakimab
Treatment: Drugs - Placebo
Experimental: Tozorakimab - Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1451) will receive a single dose of tozorakimab.
Placebo comparator: Placebo - Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1451) will receive matching placebo.
Treatment: Drugs: Tozorakimab
Single IV dose of tozorakimab on Day 1.
Treatment: Drugs: Placebo
Single IV dose of matching placebo on Day 1.
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Intervention code [1]
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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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Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
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Assessment method [1]
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To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
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Timepoint [1]
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0
by Day 28
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Secondary outcome [1]
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0
Proportion of participants who die
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Assessment method [1]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality.
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Timepoint [1]
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0
by Day 60
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Secondary outcome [2]
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0
Number of days alive and outside of Intensive Care Unit (ICU)
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Assessment method [2]
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0
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.
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Timepoint [2]
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over 28 day period
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Secondary outcome [3]
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Number of days alive and free of supplemental oxygen
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Assessment method [3]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.
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Timepoint [3]
0
0
over 28 day period
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Secondary outcome [4]
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0
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
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Assessment method [4]
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0
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
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Timepoint [4]
0
0
over 28 day and 60 day period
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Secondary outcome [5]
0
0
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
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Assessment method [5]
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0
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
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Timepoint [5]
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0
by Day 60
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Secondary outcome [6]
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Time to death (all cause)
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Assessment method [6]
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To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
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Timepoint [6]
0
0
over 28 day and 60 day period
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Secondary outcome [7]
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0
Proportion of participants who die
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Assessment method [7]
0
0
To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
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Timepoint [7]
0
0
by Day 28
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Secondary outcome [8]
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Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
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Assessment method [8]
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To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
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Timepoint [8]
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0
over 28 day and 60 day period
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Secondary outcome [9]
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Number of days alive and ventilator free
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Assessment method [9]
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0
To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
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Timepoint [9]
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0
over 28 day and 60 day period
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Secondary outcome [10]
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Proportion of participants with Intensive Care Unit (ICU) admission or death
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Assessment method [10]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
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Timepoint [10]
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by Day 28
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Secondary outcome [11]
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0
Proportion of participants with Intensive Care Unit (ICU) admission or death
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Assessment method [11]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
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Timepoint [11]
0
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by Day 60
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Secondary outcome [12]
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Proportion of participants alive and discharged
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Assessment method [12]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
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Timepoint [12]
0
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by Day 28
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Secondary outcome [13]
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Proportion of participants alive and discharged
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Assessment method [13]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
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Timepoint [13]
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by Day 60
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Secondary outcome [14]
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Time to discharge
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Assessment method [14]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
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Timepoint [14]
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over 28 day and 60 day period
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Secondary outcome [15]
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Time to being off supplemental oxygen
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Assessment method [15]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
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Timepoint [15]
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over 28 day and 60 day period
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Secondary outcome [16]
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World Health Organization (WHO) 10-category ordinal Clinical Progression Scale
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Assessment method [16]
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To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale (0 least severe to 10 most severe).
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Timepoint [16]
0
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by Day 60
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Secondary outcome [17]
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Incidence of anti-drug antibodies
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Assessment method [17]
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To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.
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Timepoint [17]
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over 60 day period
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Secondary outcome [18]
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Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint
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Assessment method [18]
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To evaluate the use of baseline serum IL-33/sST2 complex levels (U/mL) to predict treatment response with tozorakimab versus placebo as add on to Standard of Care (SoC).
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Timepoint [18]
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Day 1
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Eligibility
Key inclusion criteria
* Adult participants = 18 years old at the time of signing the informed consent form.
* Patients hospitalised with viral lung infection.
* Hypoxaemia requiring treatment with supplemental O2.
Hypoxaemia is defined as:
SpO2 = 90% OR
SpO2 = 92% AND one or both of the following:
Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement.
Use of accessory muscles of respiration or RR (respiratory rate) > 22.
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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
* Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition.
* Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
* Ongoing IMV/ECMO at randomisation.
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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 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
Recruiting
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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
13/12/2022
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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
17/03/2025
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Actual
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Sample size
Target
2902
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Recruitment hospital [2]
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Research Site - Bedford Park
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Recruitment hospital [3]
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Research Site - New Lambton Heights
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Recruitment hospital [4]
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Research Site - Port Macquarie
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Recruitment hospital [5]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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2305 - New Lambton Heights
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Recruitment postcode(s) [4]
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2444 - Port Macquarie
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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Arizona
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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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State/province [4]
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Colorado
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0
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United States of America
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State/province [5]
0
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District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
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Florida
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Country [7]
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United States of America
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State/province [7]
0
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Georgia
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Country [8]
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United States of America
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State/province [8]
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Idaho
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United States of America
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State/province [9]
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Illinois
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United States of America
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State/province [10]
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Indiana
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United States of America
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Iowa
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Country [12]
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United States of America
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Kansas
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Country [13]
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United States of America
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State/province [13]
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Louisiana
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Country [14]
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United States of America
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State/province [14]
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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New York
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United States of America
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North Carolina
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Oregon
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Rhode Island
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Texas
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Argentina
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Rosario
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Belgium
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Kortrijk
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Belgium
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Belgium
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Roeselare
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Belgium
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Yvoir
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Brazil
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Belo Horizonte
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Brazil
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Campinas
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Brazil
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Natal
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Brazil
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Niterói
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Brazil
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Porto Alegre
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Brazil
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Ribeirão Preto
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Jose Do Rio Preto
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Brazil
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Brazil
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São Paulo
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Bulgaria
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Montana
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Bulgaria
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Pernik
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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Bulgaria
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Varna
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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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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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0
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China
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Beijing
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China
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Changsha
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China
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Chengdu
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China
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Chongqing
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China
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Fuyang
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China
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Guangzhou
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China
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Haikou
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China
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Hangzhou
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China
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Hefei
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China
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Nanchang
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China
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Qingdao
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China
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Shanghai
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China
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Shenzhen
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China
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Tianjin
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China
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Weifang
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China
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Wuhan
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China
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Yantai
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China
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Yinchuan
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China
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Zhengzhou
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Colombia
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Bogota DC
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Colombia
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Floridablanca
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Colombia
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Medellin
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Colombia
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Soledad
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Colombia
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Villavicencio
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Czechia
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Benesov
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Kolin
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Czechia
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Kyjov
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Czechia
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Mlada Boleslav
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Czechia
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Praha 10
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Czechia
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Praha 5
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Denmark
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Aalborg
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Denmark
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Aarhus N
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Denmark
Query!
State/province [96]
0
0
Copenhagen Ø
Query!
Country [97]
0
0
Denmark
Query!
State/province [97]
0
0
Herning
Query!
Country [98]
0
0
Denmark
Query!
State/province [98]
0
0
Hillerød
Query!
Country [99]
0
0
Denmark
Query!
State/province [99]
0
0
Hvidovre
Query!
Country [100]
0
0
Denmark
Query!
State/province [100]
0
0
Kolding
Query!
Country [101]
0
0
Denmark
Query!
State/province [101]
0
0
København
Query!
Country [102]
0
0
Denmark
Query!
State/province [102]
0
0
Odense C
Query!
Country [103]
0
0
Denmark
Query!
State/province [103]
0
0
Vejle
Query!
Country [104]
0
0
Egypt
Query!
State/province [104]
0
0
Alexandria
Query!
Country [105]
0
0
Egypt
Query!
State/province [105]
0
0
Cairo
Query!
Country [106]
0
0
Egypt
Query!
State/province [106]
0
0
New Cairo
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Amiens Cedex 1
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Angers
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Brest Cedex
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Créteil
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Dijon
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
La Tronche
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Le Coudray Cedex
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Montpellier Cedex 5
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Nantes Cedex 1
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Orléans Cedex 2
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Strasbourg Cedex
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Strasbourg
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Tours
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Augsburg
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Berlin
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Hamburg
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Hannover
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Kiel
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Köln
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Leverkusen
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
München
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Regensburg
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Rosenheim
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Rostock
Query!
Country [131]
0
0
Greece
Query!
State/province [131]
0
0
Athens
Query!
Country [132]
0
0
Greece
Query!
State/province [132]
0
0
Exohi Thessaloniki
Query!
Country [133]
0
0
Greece
Query!
State/province [133]
0
0
Heraklion
Query!
Country [134]
0
0
Greece
Query!
State/province [134]
0
0
Ioannina
Query!
Country [135]
0
0
Greece
Query!
State/province [135]
0
0
Thessaloniki
Query!
Country [136]
0
0
Hong Kong
Query!
State/province [136]
0
0
Hong Kong
Query!
Country [137]
0
0
Hong Kong
Query!
State/province [137]
0
0
Shatin
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Balassagyarmat
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Budapest
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Debrecen
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Gyor
Query!
Country [142]
0
0
Hungary
Query!
State/province [142]
0
0
Kistarcsa
Query!
Country [143]
0
0
Hungary
Query!
State/province [143]
0
0
Nyíregyháza
Query!
Country [144]
0
0
Hungary
Query!
State/province [144]
0
0
Pécs
Query!
Country [145]
0
0
India
Query!
State/province [145]
0
0
Ahmedabad
Query!
Country [146]
0
0
India
Query!
State/province [146]
0
0
Belagavi
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Chennai
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
Gurgaon
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
Gurugram
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
Hyderabad
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Mumbai
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
New Delhi
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Pune
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Thane
Query!
Country [155]
0
0
Israel
Query!
State/province [155]
0
0
Afula
Query!
Country [156]
0
0
Israel
Query!
State/province [156]
0
0
Ashkelon
Query!
Country [157]
0
0
Israel
Query!
State/province [157]
0
0
Beer Sheva
Query!
Country [158]
0
0
Israel
Query!
State/province [158]
0
0
Haifa
Query!
Country [159]
0
0
Israel
Query!
State/province [159]
0
0
Holon
Query!
Country [160]
0
0
Israel
Query!
State/province [160]
0
0
Jerusalem
Query!
Country [161]
0
0
Israel
Query!
State/province [161]
0
0
Petah Tikva
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Ramat Gan
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Rehovot
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Arezzo
Query!
Country [165]
0
0
Italy
Query!
State/province [165]
0
0
Brescia
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Napoli
Query!
Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Roma
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Rozzano
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Torino
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Chiba-shi
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Fukuoka-shi
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Gifu-shi
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Hanyu-shi
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Hiroshima-shi
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Hitachi-shi
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Isehara-shi
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Izumisano-shi
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Izumo-shi
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Kagoshima-shi
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Kamakura-shi
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Kamogawa-shi
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Kanazawa-shi
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Kasuga-shi
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Kawasaki-shi
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Koshigaya-shi
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Kumagaya-shi
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Kumamoto-shi
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Kusatsu-shi
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Kyoto-shi
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Maebashi-shi
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Meguro-ku
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Mitaka-shi
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Nagoya-shi
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Nakagami-gun
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Nerima-ku
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Okayama-shi
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Okazaki-shi
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Omuta-shi
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Osaka-shi
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Sapporo-shi
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Shinagawa-ku
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Shinjuku-ku
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Suita-shi
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Tachikawa-shi
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Takamatsu-shi
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Urasoe-shi
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Ureshino-shi
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Yokohama-shi
Query!
Country [209]
0
0
Korea, Republic of
Query!
State/province [209]
0
0
Daegu
Query!
Country [210]
0
0
Korea, Republic of
Query!
State/province [210]
0
0
Jeonju
Query!
Country [211]
0
0
Korea, Republic of
Query!
State/province [211]
0
0
Seoul
Query!
Country [212]
0
0
Malaysia
Query!
State/province [212]
0
0
Kota Kinabalu
Query!
Country [213]
0
0
Malaysia
Query!
State/province [213]
0
0
Kuala Lumpur
Query!
Country [214]
0
0
Malaysia
Query!
State/province [214]
0
0
Kuantan
Query!
Country [215]
0
0
Malaysia
Query!
State/province [215]
0
0
Kubang Kerian
Query!
Country [216]
0
0
Malaysia
Query!
State/province [216]
0
0
Melaka
Query!
Country [217]
0
0
Malaysia
Query!
State/province [217]
0
0
Petaling Jaya
Query!
Country [218]
0
0
Malaysia
Query!
State/province [218]
0
0
Pulau Pinang
Query!
Country [219]
0
0
Malaysia
Query!
State/province [219]
0
0
Sarawak Miri
Query!
Country [220]
0
0
Malaysia
Query!
State/province [220]
0
0
Shah Alam
Query!
Country [221]
0
0
Mexico
Query!
State/province [221]
0
0
Aguascalientes
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
Ciudad de México
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
Guadalajara
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
Mexico City
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Monterrey
Query!
Country [226]
0
0
Mexico
Query!
State/province [226]
0
0
San Luis Potosi
Query!
Country [227]
0
0
Mexico
Query!
State/province [227]
0
0
Tlalpan
Query!
Country [228]
0
0
Peru
Query!
State/province [228]
0
0
Cusco
Query!
Country [229]
0
0
Peru
Query!
State/province [229]
0
0
el Agustino
Query!
Country [230]
0
0
Peru
Query!
State/province [230]
0
0
Lima
Query!
Country [231]
0
0
Peru
Query!
State/province [231]
0
0
Piura
Query!
Country [232]
0
0
Philippines
Query!
State/province [232]
0
0
Cebu
Query!
Country [233]
0
0
Philippines
Query!
State/province [233]
0
0
Iloilo City
Query!
Country [234]
0
0
Philippines
Query!
State/province [234]
0
0
Manila
Query!
Country [235]
0
0
Philippines
Query!
State/province [235]
0
0
Quezon City
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Chrzanów
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Rzeszów
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Warszawa
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Wroclaw
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Lancut
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Lódz
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Leczna
Query!
Country [243]
0
0
Puerto Rico
Query!
State/province [243]
0
0
Bayamon
Query!
Country [244]
0
0
Romania
Query!
State/province [244]
0
0
Bucharest
Query!
Country [245]
0
0
Romania
Query!
State/province [245]
0
0
Cluj-Napoca
Query!
Country [246]
0
0
Romania
Query!
State/province [246]
0
0
Constanta
Query!
Country [247]
0
0
Romania
Query!
State/province [247]
0
0
Iasi
Query!
Country [248]
0
0
Romania
Query!
State/province [248]
0
0
Sibiu
Query!
Country [249]
0
0
Romania
Query!
State/province [249]
0
0
Timisoara
Query!
Country [250]
0
0
Saudi Arabia
Query!
State/province [250]
0
0
Jeddah
Query!
Country [251]
0
0
Saudi Arabia
Query!
State/province [251]
0
0
Riyadh
Query!
Country [252]
0
0
Slovakia
Query!
State/province [252]
0
0
Bratislava
Query!
Country [253]
0
0
Slovakia
Query!
State/province [253]
0
0
Košice
Query!
Country [254]
0
0
Slovakia
Query!
State/province [254]
0
0
Trnava
Query!
Country [255]
0
0
South Africa
Query!
State/province [255]
0
0
Johannesburg, Soweto
Query!
Country [256]
0
0
South Africa
Query!
State/province [256]
0
0
Observatory
Query!
Country [257]
0
0
South Africa
Query!
State/province [257]
0
0
Parktown
Query!
Country [258]
0
0
South Africa
Query!
State/province [258]
0
0
Westdene
Query!
Country [259]
0
0
Spain
Query!
State/province [259]
0
0
Barcelona
Query!
Country [260]
0
0
Spain
Query!
State/province [260]
0
0
Madrid
Query!
Country [261]
0
0
Spain
Query!
State/province [261]
0
0
Majadahonda
Query!
Country [262]
0
0
Spain
Query!
State/province [262]
0
0
Málaga
Query!
Country [263]
0
0
Spain
Query!
State/province [263]
0
0
Ourense
Query!
Country [264]
0
0
Spain
Query!
State/province [264]
0
0
Palma de Mallorca
Query!
Country [265]
0
0
Spain
Query!
State/province [265]
0
0
Pamplona
Query!
Country [266]
0
0
Spain
Query!
State/province [266]
0
0
Santander
Query!
Country [267]
0
0
Spain
Query!
State/province [267]
0
0
Valencia
Query!
Country [268]
0
0
Sweden
Query!
State/province [268]
0
0
Helsingborg
Query!
Country [269]
0
0
Sweden
Query!
State/province [269]
0
0
Huddinge
Query!
Country [270]
0
0
Sweden
Query!
State/province [270]
0
0
Lund
Query!
Country [271]
0
0
Sweden
Query!
State/province [271]
0
0
Malmö
Query!
Country [272]
0
0
Sweden
Query!
State/province [272]
0
0
Solna
Query!
Country [273]
0
0
Sweden
Query!
State/province [273]
0
0
Stockholm
Query!
Country [274]
0
0
Sweden
Query!
State/province [274]
0
0
Umeå
Query!
Country [275]
0
0
Sweden
Query!
State/province [275]
0
0
Västerås
Query!
Country [276]
0
0
Taiwan
Query!
State/province [276]
0
0
Kaohsiung
Query!
Country [277]
0
0
Taiwan
Query!
State/province [277]
0
0
Taichung
Query!
Country [278]
0
0
Taiwan
Query!
State/province [278]
0
0
Taipei
Query!
Country [279]
0
0
Taiwan
Query!
State/province [279]
0
0
Taoyuan City
Query!
Country [280]
0
0
Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Banphaeo
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Thailand
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Chiang Mai
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Thailand
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Khon-Kaen
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Thailand
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Phutthamonthon
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Thailand
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Ubonratchathani
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Istambul
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Izmit
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Turkey
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Malatya
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United Kingdom
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Bristol
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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United Kingdom
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Hampshire
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Prescot
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United Kingdom
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Tyne And Wear
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United Kingdom
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Wythenshawe
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Vietnam
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Hai Phong
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Vietnam
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Hanoi
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Ho Chi Minh
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Vietnam
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Hochiminh city
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Vietnam
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Hue
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
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Trial website
https://clinicaltrials.gov/study/NCT05624450
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Address
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Phone
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1-877-240-9479
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[email protected]
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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)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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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 not provided in
https://clinicaltrials.gov/study/NCT05624450