"Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania"
NCT ID: NCT03241901
Last Updated: 2018-03-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
280 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-27
Study Completion Date
2018-02-17
Brief Summary
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This clinical trial evaluates the advantage of prolonging the therapeutic life span of Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine 0.25mg/kg. The study will have two arms, one that will receive standard treatment of uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the prolonged dose of 6 days together with single low dose primaquine. This approach is expected to provide strategies for malaria control in an era of imminent Plasmodium falciparum resistance.
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Detailed Description
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Despite documented high cure rates of ACT in Tanzania, and Africa elsewhere, clinical trials conducted in Tanzania with Swedish International Development cooperation Agency (SIDA) and Swedish Research Council support, provide evidence for in vivo selection of lumefantrine tolerant/resistant parasites among recurrent infections. Similarly, molecular epidemiology studies from Bagamoyo District, Tanzania, have shown temporal selection of lumefantrine associated genetic tolerance/resistance markers in the parasite population following wide scale use of Artemether-lumefantrine, but without signs of compromised treatment efficacy.
During the last decade, and despite the documented rapid microscopy determined parasite clearance of artemether-lumefantrine in Bagamoyo District, interest has developed in understanding the observation of high residual polymerase chain reaction (PCR) determined positivity rate on day 3 after supervised artemether-lumefantrine treatment in the magnitude of almost 30% in previous assessments from 2015. Using deep sequencing approaches studies have recently detected PCR determined delayed parasite clearance curves in P. falciparum sub-populations in Bagamoyo District. The clearance times by PCR of these sub-populations were similar to artemisinin resistant parasites in Myanmar as assessed by microscopy, but the former did, importantly, not harbor any of the described mutations in Kelch13 propeller associated with artemisinin resistance. However, these Tanzanian parasite sub-populations need to be further studied and characterized since they may provide important clues to the understanding of artemisinin survival strategies among the East African P. falciparum parasite population.
Taken together, longitudinal clinical and molecular data described above from Tanzania, East Africa, extending from pre-ACT implementation, (before 2006), to a decade of wide scale artemether-lumefantrine use in Bagamoyo district, provide evidence for declining susceptibility to ACT, both to artemether and lumefantrine, among the P. falciparum population. These parasites ("last man standing") that survived 10 years of ACT exposure have indeed shown excellent survival instincts and may thus be particularly resistant prone. However, if P. falciparum resistance to ACT develops in Africa, this will have devastating effects on malaria morbidity and mortality and may swiftly ruin the improvements the global malaria community achieved during the past decade with ACT as a key component for success.
Based on the above the investigators suggest prolonged treatment with ACT and addition of transmission blocking treatment using a single low dose of primaquine administered on the last day of ACT treatment.
During the last decade, and despite the documented rapid microscopy determined parasite clearance of artemether-lumefantrine in Bagamoyo District, interest has developed in understanding the observation of high residual polymerase chain reaction (PCR) determined positivity rate on day 3 after supervised artemether-lumefantrine treatment in the magnitude of almost 30% in previous assessments from 2015. Using deep sequencing approaches studies have recently detected PCR determined delayed parasite clearance curves in P. falciparum sub-populations in Bagamoyo District. The clearance times by PCR of these sub-populations were similar to artemisinin resistant parasites in Myanmar as assessed by microscopy, but the former did, importantly, not harbor any of the described mutations in Kelch13 propeller associated with artemisinin resistance. However, these Tanzanian parasite sub-populations need to be further studied and characterized since they may provide important clues to the understanding of artemisinin survival strategies among the East African P. falciparum parasite population.
Taken together, longitudinal clinical and molecular data described above from Tanzania, East Africa, extending from pre-ACT implementation, (before 2006), to a decade of wide scale artemether-lumefantrine use in Bagamoyo district, provide evidence for declining susceptibility to ACT, both to artemether and lumefantrine, among the P. falciparum population. These parasites ("last man standing") that survived 10 years of ACT exposure have indeed shown excellent survival instincts and may thus be particularly resistant prone. However, if P. falciparum resistance to ACT develops in Africa, this will have devastating effects on malaria morbidity and mortality and may swiftly ruin the improvements the global malaria community achieved during the past decade with ACT as a key component for success.
Based on the above the investigators suggest prolonged treatment with ACT and addition of transmission blocking treatment using a single low dose of primaquine administered on the last day of ACT treatment.
Conditions
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Malaria,Falciparum
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Due to the objectives of the study, the identity of test and control treatments will be known only to investigators, research staff, but NOT patients. The following study procedures will be in place to ensure single-blind administration of study treatments.
1. Access to the randomization code will be strictly controlled.
2. A taste-matching agent for the placebo.
3. Packaging and labeling of test and control treatments will be identical to maintain the blind.
During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. When possible, the Investigator should discuss the emergency with the Medical Monitor prior to un-blinding
1. Access to the randomization code will be strictly controlled.
2. A taste-matching agent for the placebo.
3. Packaging and labeling of test and control treatments will be identical to maintain the blind.
During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. When possible, the Investigator should discuss the emergency with the Medical Monitor prior to un-blinding
Study Groups
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3 Days Artemether-Lumefantrine + Placebo
Oral tablets of artemether-lumefantrine (20-120mg):
1. tablet for 5-14kg;
2. tablets for 15-24 kg;
3. tables for 25 - 34kg and
4. tablets for above 35 Kg. The full course of treatment is 6-doses for 3 days given twice daily, at 0, 8, 24, 36, 48, 60 with the dose being given as directly observed therapy.
Oral placebo after completion of the standard 3 days-six dose regimen. A fatty snack (biscuits) will be administered together with all artemether-lumefantrine doses to optimize absorption.
Group Type
ACTIVE_COMPARATOR
Artemether-Lumefantrine Tab 20-120mg
Intervention Type
DRUG
Artemether-Lumefantrine Tablet 20-120mg
Placebo
Intervention Type
OTHER
Aqueous solution prepared to mimic the taste of the intervention drug.
6Days Artemether/Lumefantrine+Primaquine
Artemether-lumefantrine (20-120mg) twice daily for 6 days according to body weight as in the active comparator arm.
And in addition to that, , a single 0.25 mg/kg primaquine dose (Primaquine phosphate) will be administered concomitantly with the last (i.e. twelfth) artemether-lumefantrine dose. Primaquine will be prepared and administered in an aqueous solution.
Group Type
EXPERIMENTAL
Artemether-Lumefantrine Tab 20-120mg
Intervention Type
DRUG
Artemether-Lumefantrine Tablet 20-120mg
Primaquine Phosphate 0.25 mg/kg
Intervention Type
DRUG
Primaquine Phosphate 0.25 mg/kg
Interventions
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Artemether-Lumefantrine Tab 20-120mg
Artemether-Lumefantrine Tablet 20-120mg
Intervention Type
DRUG
Primaquine Phosphate 0.25 mg/kg
Primaquine Phosphate 0.25 mg/kg
Intervention Type
DRUG
Placebo
Aqueous solution prepared to mimic the taste of the intervention drug.
Intervention Type
OTHER
Other Intervention Names
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ALU
PQ
Placebo for Artemether Lumefantrine + Primaquine Phosphate
Eligibility Criteria
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Inclusion Criteria
1. Age more than 1 year and less than 65 years.
2. Weight 10 kg and above;
3. Body temperature ≥37.5°C or history of fever in the last 24 hours;
4. Microscopy determined asexual P. falciparum mono-infection regardless of parasitemia
5. Normal - corrected QT Interval in Baseline ECG of less than 440ms in male and 460ms in females
2. Weight 10 kg and above;
3. Body temperature ≥37.5°C or history of fever in the last 24 hours;
4. Microscopy determined asexual P. falciparum mono-infection regardless of parasitemia
5. Normal - corrected QT Interval in Baseline ECG of less than 440ms in male and 460ms in females
Exclusion Criteria
1. Symptoms/signs of severe malaria or danger signs;
2. Pregnancy, Breastfeeding or unwilling to practice birth control during participation in the study.
3. Known allergy to study medications;
4. Hb \<8 g/dl;
5. Reported antimalarial intake within last 2 weeks;
6. On regular medication, which may interfere with antimalarial pharmacokinetics and
7. Blood transfusion within last 90 days.
2. Pregnancy, Breastfeeding or unwilling to practice birth control during participation in the study.
3. Known allergy to study medications;
4. Hb \<8 g/dl;
5. Reported antimalarial intake within last 2 weeks;
6. On regular medication, which may interfere with antimalarial pharmacokinetics and
7. Blood transfusion within last 90 days.
Minimum Eligible Age
1 Year
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Uppsala University
OTHER
Sponsor Role
collaborator
Karolinska Institutet
OTHER
Sponsor Role
collaborator
The University of Western Australia
OTHER
Sponsor Role
collaborator
Muhimbili University of Health and Allied Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Lwidiko Edward
Medical Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lwidiko E Mhamilawa, MD
Role: PRINCIPAL_INVESTIGATOR
Muhimbili University of Health and Allied Sciences
Andreas Martensson, PhD
Role: STUDY_CHAIR
Uppsala University
Locations
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Fukayosi Dispensary
Bagamoyo, Coast Region, Tanzania
Site Status
Yombo Dispensary
Bagamoyo, Yombo, Tanzania
Site Status
Countries
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Tanzania
References
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Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, Gil JP. In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005 Mar 15;191(6):1014-7. doi: 10.1086/427997. Epub 2005 Feb 8.
Reference Type
BACKGROUND
Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.
Reference Type
BACKGROUND
Malmberg M, Ngasala B, Ferreira PE, Larsson E, Jovel I, Hjalmarsson A, Petzold M, Premji Z, Gil JP, Bjorkman A, Martensson A. Temporal trends of molecular markers associated with artemether-lumefantrine tolerance/resistance in Bagamoyo district, Tanzania. Malar J. 2013 Mar 18;12:103. doi: 10.1186/1475-2875-12-103.
Reference Type
BACKGROUND
Mideo N, Bailey JA, Hathaway NJ, Ngasala B, Saunders DL, Lon C, Kharabora O, Jamnik A, Balasubramanian S, Bjorkman A, Martensson A, Meshnick SR, Read AF, Juliano JJ. A deep sequencing tool for partitioning clearance rates following antimalarial treatment in polyclonal infections. Evol Med Public Health. 2016 Jan 27;2016(1):21-36. doi: 10.1093/emph/eov036.
Reference Type
BACKGROUND
Mwaiswelo R, Ngasala BE, Jovel I, Gosling R, Premji Z, Poirot E, Mmbando BP, Bjorkman A, Martensson A. Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. Malar J. 2016 Jun 10;15:316. doi: 10.1186/s12936-016-1341-3.
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R. Mwaiswelo, B. Ngasala, I. Jovel, W. Xu, and M. Malmberg, "Occurrence of day 3 submicroscopic Plasmodium falciparum parasitemia before and after implementation of artemether-lumefantrine treatment policy in Tanzania .," Dar Es Salaam, 2016
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Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859.
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Ariey F, Witkowski B, Amaratunga C, Beghain J, Langlois AC, Khim N, Kim S, Duru V, Bouchier C, Ma L, Lim P, Leang R, Duong S, Sreng S, Suon S, Chuor CM, Bout DM, Menard S, Rogers WO, Genton B, Fandeur T, Miotto O, Ringwald P, Le Bras J, Berry A, Barale JC, Fairhurst RM, Benoit-Vical F, Mercereau-Puijalon O, Menard D. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria. Nature. 2014 Jan 2;505(7481):50-5. doi: 10.1038/nature12876. Epub 2013 Dec 18.
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Witkowski B, Amaratunga C, Khim N, Sreng S, Chim P, Kim S, Lim P, Mao S, Sopha C, Sam B, Anderson JM, Duong S, Chuor CM, Taylor WR, Suon S, Mercereau-Puijalon O, Fairhurst RM, Menard D. Novel phenotypic assays for the detection of artemisinin-resistant Plasmodium falciparum malaria in Cambodia: in-vitro and ex-vivo drug-response studies. Lancet Infect Dis. 2013 Dec;13(12):1043-9. doi: 10.1016/S1473-3099(13)70252-4. Epub 2013 Sep 11.
Reference Type
BACKGROUND
Straimer J, Gnadig NF, Witkowski B, Amaratunga C, Duru V, Ramadani AP, Dacheux M, Khim N, Zhang L, Lam S, Gregory PD, Urnov FD, Mercereau-Puijalon O, Benoit-Vical F, Fairhurst RM, Menard D, Fidock DA. Drug resistance. K13-propeller mutations confer artemisinin resistance in Plasmodium falciparum clinical isolates. Science. 2015 Jan 23;347(6220):428-31. doi: 10.1126/science.1260867. Epub 2014 Dec 11.
Reference Type
BACKGROUND
Malmberg M, Ferreira PE, Tarning J, Ursing J, Ngasala B, Bjorkman A, Martensson A, Gil JP. Plasmodium falciparum drug resistance phenotype as assessed by patient antimalarial drug levels and its association with pfmdr1 polymorphisms. J Infect Dis. 2013 Mar 1;207(5):842-7. doi: 10.1093/infdis/jis747. Epub 2012 Dec 5.
Reference Type
BACKGROUND
Linder E, Lundin M, Thors C, Lebbad M, Winiecka-Krusnell J, Helin H, Leiva B, Isola J, Lundin J. Web-based virtual microscopy for parasitology: a novel tool for education and quality assurance. PLoS Negl Trop Dis. 2008;2(10):e315. doi: 10.1371/journal.pntd.0000315. Epub 2008 Oct 22.
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BACKGROUND
Lundin M, Szymas J, Linder E, Beck H, de Wilde P, van Krieken H, Garcia Rojo M, Moreno I, Ariza A, Tuzlali S, Dervisoglu S, Helin H, Lehto VP, Lundin J. A European network for virtual microscopy--design, implementation and evaluation of performance. Virchows Arch. 2009 Apr;454(4):421-9. doi: 10.1007/s00428-009-0749-3. Epub 2009 Mar 12.
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BACKGROUND
Aydin-Schmidt B, Xu W, Gonzalez IJ, Polley SD, Bell D, Shakely D, Msellem MI, Bjorkman A, Martensson A. Loop mediated isothermal amplification (LAMP) accurately detects malaria DNA from filter paper blood samples of low density parasitaemias. PLoS One. 2014 Aug 8;9(8):e103905. doi: 10.1371/journal.pone.0103905. eCollection 2014.
Reference Type
BACKGROUND
Cook J, Aydin-Schmidt B, Gonzalez IJ, Bell D, Edlund E, Nassor MH, Msellem M, Ali A, Abass AK, Martensson A, Bjorkman A. Loop-mediated isothermal amplification (LAMP) for point-of-care detection of asymptomatic low-density malaria parasite carriers in Zanzibar. Malar J. 2015 Jan 28;14:43. doi: 10.1186/s12936-015-0573-y.
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BACKGROUND
Aydin-Schmidt B, Morris U, Ding XC, Jovel I, Msellem MI, Bergman D, Islam A, Ali AS, Polley S, Gonzalez IJ, Martensson A, Bjorkman A. Field Evaluation of a High Throughput Loop Mediated Isothermal Amplification Test for the Detection of Asymptomatic Plasmodium Infections in Zanzibar. PLoS One. 2017 Jan 17;12(1):e0169037. doi: 10.1371/journal.pone.0169037. eCollection 2017.
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BACKGROUND
Xu W, Morris U, Aydin-Schmidt B, Msellem MI, Shakely D, Petzold M, Bjorkman A, Martensson A. SYBR Green real-time PCR-RFLP assay targeting the plasmodium cytochrome B gene--a highly sensitive molecular tool for malaria parasite detection and species determination. PLoS One. 2015 Mar 16;10(3):e0120210. doi: 10.1371/journal.pone.0120210. eCollection 2015.
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Mlambo G, Vasquez Y, LeBlanc R, Sullivan D, Kumar N. A filter paper method for the detection of Plasmodium falciparum gametocytes by reverse transcription polymerase chain reaction. Am J Trop Med Hyg. 2008 Jan;78(1):114-6.
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Schneider P, Reece SE, van Schaijk BC, Bousema T, Lanke KH, Meaden CS, Gadalla A, Ranford-Cartwright LC, Babiker HA. Quantification of female and male Plasmodium falciparum gametocytes by reverse transcriptase quantitative PCR. Mol Biochem Parasitol. 2015 Jan-Feb;199(1-2):29-33. doi: 10.1016/j.molbiopara.2015.03.006. Epub 2015 Mar 28.
Reference Type
BACKGROUND
Froberg G, Jornhagen L, Morris U, Shakely D, Msellem MI, Gil JP, Bjorkman A, Martensson A. Decreased prevalence of Plasmodium falciparum resistance markers to amodiaquine despite its wide scale use as ACT partner drug in Zanzibar. Malar J. 2012 Sep 11;11:321. doi: 10.1186/1475-2875-11-321.
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BACKGROUND
Veiga MI, Ferreira PE, Bjorkman A, Gil JP. Multiplex PCR-RFLP methods for pfcrt, pfmdr1 and pfdhfr mutations in Plasmodium falciparum. Mol Cell Probes. 2006 Apr;20(2):100-4. doi: 10.1016/j.mcp.2005.10.003. Epub 2006 Feb 7.
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Price RN, Uhlemann AC, Brockman A, McGready R, Ashley E, Phaipun L, Patel R, Laing K, Looareesuwan S, White NJ, Nosten F, Krishna S. Mefloquine resistance in Plasmodium falciparum and increased pfmdr1 gene copy number. Lancet. 2004 Jul 31-Aug 6;364(9432):438-447. doi: 10.1016/S0140-6736(04)16767-6.
Reference Type
BACKGROUND
Mhamilawa LE, Wikstrom S, Mmbando BP, Ngasala B, Martensson A. Electrocardiographic safety evaluation of extended artemether-lumefantrine treatment in patients with uncomplicated Plasmodium falciparum malaria in Bagamoyo District, Tanzania. Malar J. 2020 Jul 14;19(1):250. doi: 10.1186/s12936-020-03309-2.
Reference Type
DERIVED
Mhamilawa LE, Ngasala B, Morris U, Kitabi EN, Barnes R, Soe AP, Mmbando BP, Bjorkman A, Martensson A. Parasite clearance, cure rate, post-treatment prophylaxis and safety of standard 3-day versus an extended 6-day treatment of artemether-lumefantrine and a single low-dose primaquine for uncomplicated Plasmodium falciparum malaria in Bagamoyo district, Tanzania: a randomized controlled trial. Malar J. 2020 Jun 23;19(1):216. doi: 10.1186/s12936-020-03287-5.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf
"WHO World Malaria Report 2015," Geneva, Switzerland, 2015
http://apps.who.int/iris/bitstream/10665/162441/1/9789241549127_eng.pdf
WHO guidelines for the treatment of malaria 2015, 3rd Edition. Geneva, Switzerland, 2015
https://www.pmi.gov/docs/default-source/default-document-library/malaria-operational-plans/fy-15/fy-2015-tanzania-malaria-operational-plan.pdf?sfvrsn=3
PRESIDENT'S MALARIA INITIATIVE Tanzania Malaria Operational Plan FY 2015
Other Identifiers
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No. 01.05.2017
Identifier Type: -
Identifier Source: org_study_id
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