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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01218516
Registration number
NCT01218516
Ethics application status
Date submitted
7/10/2010
Date registered
11/10/2010
Date last updated
20/08/2020
Titles & IDs
Public title
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)
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Secondary ID [1]
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2010-022229-13
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Secondary ID [2]
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MORAb-003-009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of the Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Farletuzumab
Other interventions - Placebo
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Active Comparator: Farletuzumab plus Chemotherapy - During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
Placebo Comparator: Placebo plus Chemotherapy - During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.
Other interventions: Farletuzumab
Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.
Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
Other interventions: Placebo
Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.
Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
Treatment: Drugs: Carboplatin
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6].
Treatment: Drugs: Paclitaxel
Paclitaxel 200 mg/m^2 will be administered intravenously.
Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously.
Treatment: Drugs: Cisplatin
Cisplatin 75 mg/m^2 will be administered intravenously.
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Intervention code [1]
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Other interventions
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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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Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).
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Timepoint [1]
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From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
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Timepoint [1]
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From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
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Secondary outcome [2]
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Duration of Response (DR)
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Assessment method [2]
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DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [2]
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From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.
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Timepoint [3]
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From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis
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Secondary outcome [4]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
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Assessment method [4]
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An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
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Timepoint [4]
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For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the lung classified as
stage IV
- Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
- Measurable disease with at least one unidimensionally measurable lesion according to
RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging
(MRI) scans (CT or MRI scans must have been performed within 30 days prior to the
first dose of farletuzumab or placebo)
- Must have received no prior chemotherapy, radiation therapy or surgery with curative
intent for adenocarcinoma of the lung
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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
- Participants who have had previous chemotherapy for adenocarcinoma of the lung
- Prior surgery with curative intent for adenocarcinoma of the lung
- Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local
radiotherapy for symptom control [i.e., palliative radiation with non-curative intent]
is permitted)
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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 2
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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
27/06/2011
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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
1/11/2013
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Sample size
Target
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Accrual to date
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Final
130
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [2]
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Southern Medical Day Oncology Care Centre - Wollongong
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital, Dept. of Medical Oncology - Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital, Cancer Centre - Adelaide
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Recruitment hospital [6]
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Flinders Medical Centre, Dept. of Oncology - Bedford Park
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Recruitment hospital [7]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [8]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [9]
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Box Hill Hospital - Box Hill
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Frankston Hospital, Oncology Day Unit - Frankston
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Epworth Healthcare - Richmond
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Recruitment hospital [12]
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Fremantle Hospital - Fremantle
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2485 - Tweed Heads
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2500 - Wollongong
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4029 - Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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Recruitment postcode(s) [6]
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5042 - Bedford Park
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Recruitment postcode(s) [7]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [8]
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5011 - Woodville South
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Recruitment postcode(s) [9]
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3128 - Box Hill
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3199 - Frankston
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Recruitment postcode(s) [11]
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3002 - Richmond
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Recruitment postcode(s) [12]
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6160 - Fremantle
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Recruitment outside Australia
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Malaga
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Barcelona
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Morphotek
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to compare the effect of farletuzumab versus placebo
in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent
(carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on
investigator-assessed progression free survival (PFS) as determined by Response Evaluation
Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new
occurrence of positive fluid cytology) in chemotherapy naive participants with folate
receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01218516
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01218516
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