- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00614939
Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
16. maj 2011 opdateret af: AstraZeneca
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes.
This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
572
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dimitrovgrad, Bulgarien
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Sofia, Bulgarien
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Veliko Tarnovo, Bulgarien
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Chelyabinsk, Den Russiske Føderation
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Moscow, Den Russiske Føderation
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Ryazan, Den Russiske Føderation
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St.petersburg, Den Russiske Føderation
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Yaroslavl, Den Russiske Føderation
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Tallinn, Estland
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California
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Concord, California, Forenede Stater
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Sacramento, California, Forenede Stater
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Colorado
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Denver, Colorado, Forenede Stater
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Kansas
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Topeka, Kansas, Forenede Stater
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Maryland
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Baltimore, Maryland, Forenede Stater
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Montana
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Great Falls, Montana, Forenede Stater
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North Carolina
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Greenville, North Carolina, Forenede Stater
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Morehead City, North Carolina, Forenede Stater
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Ohio
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Cincinnati, Ohio, Forenede Stater
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Texas
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Corpus Christi, Texas, Forenede Stater
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West Virginia
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Charleston, West Virginia, Forenede Stater
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Brest, Hviderusland
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Gomel, Hviderusland
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Minsk, Hviderusland
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Karlovac, Kroatien
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Osijek, Kroatien
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Rijeka, Kroatien
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Split, Kroatien
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Zagreb, Kroatien
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Riga, Letland
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Kaunas, Litauen
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Klaipeda, Litauen
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Panevezys, Litauen
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Vilnius, Litauen
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Bialystok, Polen
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Ciechanow, Polen
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Golub Dobrzyn, Polen
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Grodzisk Mazowiecki, Polen
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Katowice, Polen
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Krakow, Polen
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Makow Mazowiecki, Polen
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Radom, Polen
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Szczecin, Polen
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Warszawa, Polen
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Wroclaw, Polen
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Zabrze, Polen
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90-153
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Lodz, 90-153, Polen
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Bacau, Rumænien
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Brasov, Rumænien
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Bucharest, Rumænien
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Bucuresti, Rumænien
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Sf Gheorghe, Rumænien
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Satu Mare
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Satu-mare, Satu Mare, Rumænien
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Moravsky Krumlov, Tjekkiet
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Praha 10, Tjekkiet
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Teplice, Tjekkiet
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Usti Nad Labem, Tjekkiet
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Znojmo, Tjekkiet
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Dieburg, Tyskland
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Dusseldorf, Tyskland
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Hannover, Tyskland
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Heidelberg, Tyskland
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Mannheim, Tyskland
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Dnipropetrovsk, Ukraine
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Ivano-frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Mykolayiv, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Zaporizhzhya, Ukraine
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Debrecen, Ungarn
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Gyor, Ungarn
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Kalocsa, Ungarn
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Kecskemet, Ungarn
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Zalaegerszeg, Ungarn
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosed with type 2 diabetes
- Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
- HbA1c ≥7.0% and ≤11.0%
Exclusion Criteria:
- Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
- Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Saxa
Saxagliptin
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2.5 mg once daily oral dose
Andre navne:
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Ingen indgriben: Placebo
Placebo to match
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Placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
Tidsramme: Baseline , Week 12 (LOCF)
|
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set).
HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
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Baseline , Week 12 (LOCF)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup
Tidsramme: Baseline, Week 12 (LOCF)
|
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
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Baseline, Week 12 (LOCF)
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup
Tidsramme: Baseline, Week 12 (LOCF)
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Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
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Baseline, Week 12 (LOCF)
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup
Tidsramme: Baseline, Week 12 (LOCF)
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Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
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Baseline, Week 12 (LOCF)
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup
Tidsramme: Baseline, Week 12 (LOCF)
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Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
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Baseline, Week 12 (LOCF)
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Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Tidsramme: Baseline , Week 52
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Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set).
HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
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Baseline , Week 52
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Tidsramme: Baseline, Week 52
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Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
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Baseline, Week 52
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup
Tidsramme: Baseline, Week 52
|
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
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Baseline, Week 52
|
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup
Tidsramme: Baseline, Week 52
|
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
|
Baseline, Week 52
|
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
Tidsramme: Baseline, Week 52
|
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup.
FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value
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Baseline, Week 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Peter Öhman, MD, PhD, AstraZeneca
- Studiestol: Deborah Price, MSc, AstraZeneca
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
31. januar 2008
Først indsendt, der opfyldte QC-kriterier
12. februar 2008
Først opslået (Skøn)
13. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. maj 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2011
Sidst verificeret
1. maj 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Nyreinsufficiens
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Saxagliptin
Andre undersøgelses-id-numre
- D1680C00007
- EudraCT number 2007-004951-12
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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