FrancophonIA/ELRC3.0 huggingface dataset:
English: - With clean hands, place Ledaga back in the box it came in and the box in the plastic bag.
Danish: - Læg Ledaga tilbage i æsken, det blev leveret i, med rene hænder, og læg æsken i plasticposen.
English: Diethylene glycol monoethyl ether Propylene glycol
Danish: Diethylenglycolmonoethylether Propylenglycol
English: In case of Ledaga exposure to non-affected areas of the skin, wash the exposed area with soap and water.
Danish: I tilfælde af utilsigtet eksponering af Ledaga på ikke-afficerede hudområder skal de eksponerede områder vaskes med sæbe og vand.
English: Use the cap to pierce the seal.
Danish: Brug hætten til at perforere forseglingen.
English: Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for chlormethin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, and these may be severe.
Danish: Eksponering af slimhinder, f.eks. i mund og næse forårsager smerter, rødme og ulceration, som kan være alvorlig.
English: How to use Ledaga
Danish: Sådan skal du bruge Ledaga
English: Other side effects may include
Danish: Andre bivirkninger
English: If it is not, ask your pharmacist.
Danish: Spørg på apoteket, hvis dette ikke er tilfældet.
English: - Contact with your eyes must be avoided.
Danish: - Du skal undgå, at Ledaga kommer i kontakt med øjnene.
English: If you apply more than recommended, talk to your doctor.
Danish: Kontakt lægen, hvis du har påført mere end den anbefalede dosis.
English: - Direct skin contact with Ledaga should be avoided in individuals other than the patient, such as caregivers.
Danish: - Andre personer end patienter, f.eks. omsorgspersoner, skal undgå direkte hudkontakt med Ledaga.
English: Ledaga should be removed from the refrigerator just prior to application and returned to the refrigerator immediately after each use in its box inside the child-resistant, transparent, sealable, plastic bag.
Danish: Umiddelbart efter brug skal Ledaga lægges tilbage i æsken, der lægges i den børnesikrede, gennemsigtige plasticpose med forsegling og placeres i køleskab igen.
English: What Ledaga is and what it is used for What you need to know before you use Ledaga How to use Ledaga
Danish: Det skal du vide, før du begynder at bruge Ledaga Sådan skal du bruge Ledaga Bivirkninger
English: If you use Ledaga more than you should
Danish: Hvis du har brugt for meget Ledaga
English: Posology
Danish: Mælkesyre
English: What Ledaga looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Do not take two doses in one day.
Danish: Tag ikke to doser på én dag.
English: Date of first authorisation: 16 May 2018
Danish: Dato for første markedsføringstilladelse: 16. maj 2018
English: Patients may be counted in more than one row.
Danish: Patienterne kan tælles i mere end én række.
English: • ≥75 years of age (see below).
Danish: • ≥ 75 år (se nedenunder).
English: It may be administered with or without food.
Danish: Det kan administreres med eller uden føde.
English: You may take Prasugrel Mylan with or without food.
Danish: Du kan tage Prasugrel Mylan med eller uden mad.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The patient population was 92% Caucasian, 26% female, and 39% ≥65 years of age.
Danish: Patientpopulationen bestod af 92 % kaukasiere, 26 % kvinder og 39 % ≥ 65 år.
English: • Sudden difficulty in walking or loss of balance or co-ordination
Danish: • Pludseligt besvær med at gå eller problemer med balance og koordination
English: 117 Allee des Parcs, 69 800 Saint Priest, France
Danish: 117 Allee des Parcs, 69 800 Saint Priest, Frankrig
English: The tablets should not be crushed or broken.
Danish: Tabletterne bør ikke knuses eller knækkes.
English: • Uncontrollable bleeding, for example from a cut
Danish: • Ukontrolleret blødning fra for eksempel et snitsår
English: Group criteria.
Danish: Study Group-kriterierne.
English: • Sudden confusion, difficulty speaking or understanding others
Danish: • Pludselig forvirring, talebesvær eller svært ved at forstå andre
English: Patients ≥75 years old
Danish: Patienter ≥ 75 år
English: • Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body
Danish: • Pludselig følelsesløshed eller svaghed i arme, ben eller ansigt, særlig hvis det kun er i den ene side af kroppen
English: 18 months.
Danish: 7 dage.
English: The benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study.
Danish: Fordelen ved prasugrel viste sig inden for de første 3 dage og varede ved til slutningen af forsøget.
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Danish: Fordeling Den aktive metabolits binding til humant serumalbumin (4 % bufferopløsning) var 98 %.
English: Yes (N=518)
Danish: Ja (N = 518)
English: For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab.
Danish: For alle patienterne kunne støddosis administreres til enhver tid mellem randomisering og 1 time efter, at patienten forlod katerisationslaboratoriet.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystemanført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale indberetningssystem anført i Appendiks V.
English: All ACS population
Danish: Total AKS-population
English: McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland
Danish: McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Irland
English: • Sudden dizziness or sudden severe headache with no known cause
Danish: • Pludselig svimmelhed eller pludselig, voldsom hovedpine af ukendt årsag
English: Table 3: Patients with outcome events in TRITON primary analysis
Danish: Tabel 3: Patienter med endepunktshændelser i TRITON-primæranalysen
English: Polyvinyl alcohol
Danish: Polyvinylalkohol Talkum
English: Because animal reproduction studies are not always predictive of a human response, Prasugrel Mylan should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Danish: Eftersom reproduktionsforsøg hos dyr ikke altid kan forudsige det humane respons, bør Prasugrel Mylan kun anvendes under graviditet, hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: No (N=13090)
Danish: Nej (N = 13.090)
English: You should use Prasugrel Mylan only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Danish: Du må kun tage Prasugrel Mylan, hvis du har talt med din læge om de mulige fordele og enhver eventuel risiko for dit ufødte barn.
English: Do not take Prasugrel Mylan if you - are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Prasugrel Mylan, hvis du - er allergisk over for prasugrel eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: Prasugrel was administered without regard to food in TRITON.
Danish: Prasugrel blev administreret uden hensyn til føde i TRITON.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Danish: LÆGEMIDDELFORM Filmovertrukket tablet (tablet).
English: TTP has been reported with the use of prasugrel.
Danish: Der er indberettet TTP ved brug af prasugrel.
English: The observed benefit of prasugrel in patients ≥75 years was less than that observed in patients <75 years.
Danish: Den observerede fordel ved prasugrel hos patienter ≥ 75 år var mindre end den, som blev observeret hos patienter < 75 år.
English: • If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Prasugrel Mylan.
Danish: • Hvis du har haft allergiske reaktioner (overfølsomhed) over for clopidogrel eller andre blodfortyndende midler, skal du fortælle det til din læge, inden du påbegynder behandling med Prasugrel Mylan.
English: If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Prasugrel Mylan should be discontinued at least 7 days prior to surgery.
Danish: Hvis en patient skal have foretaget elektiv kirurgi, og antitrombotisk virkning ikke er ønskelig, bør Prasugrel Mylan seponeres mindst 7 dage forud for indgrebet.
English: The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel.
Danish: Protokollen for det kliniske studie foreskrev, at alle patienter fik acetylsalicylsyre og en daglig vedligeholdelsesdosis af prasugrel.
English: At a very high dose (>240 times the recommended daily human maintenance dose on a mg/m² basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Danish: Ved en meget høj dosis (> 240 gange den anbefalede daglige humane vedligeholdelsesdosis på basis af mg/m²), som påvirkede moderens kropsvægt og/eller fødeindtagelse, var der et let fald i afkommets legemsvægt (i forhold til kontroller).
English: All of the above may be signs of bleeding, the most common side effect with Prasugrel Mylan.
Danish: Alt det ovennævnte kan være tegn på blødning, som er den mest almindelige bivirkning ved Prasugrel Mylan.
English: Children and adolescents Prasugrel Mylan should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge Prasugrel Mylan må ikke anvendes af børn og unge under 18 år.
English: • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Danish: • ved samtidig administration af lægemidler, som kan øge blødningsrisikoen, herunder orale antikoagulantia, clopidogrel, non-steroide antiinflammatoriske lægemidler (NSAIDs) og fibrinolytika.
English: Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Prasugrel Mylan.
Danish: Fortæl det til din læge, hvis du bliver gravid eller forsøger at blive gravid, medens du tager Prasugrel Mylan.
English: If you are pregant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p<0.001) for prasugrel versus clopidogrel.
Danish: I den totale AKS-population viste en analyse af hvert af de sekundære endepunkter en signifikant fordel (p < 0.001) ved prasugrel sammenlignet med clopidogrel.
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Danish: Tabel 1: Incidens af ikke-CABG-relateret blødninga (% patienter)
English: The reduction in stent thrombosis with prasugrel was observed both early and beyond 30 days for both bare metal and drug eluting stents.
Danish: Reduktionen af stenttrombose med prasugral blev observeret både tidligt og efter 30 dage for både rene metalstents og medicingivende stents.
English: Prasugrel Mylan is for oral use.
Danish: Prasugrel Mylan er til oral brug.
English: Your doctor may wish you to stop taking Prasugrel Mylan temporarily due to the increased risk of bleeding
Danish: Din læge vil bede dig stoppe med at tage Prasugrel Mylan midlertidigt på grund af øget risiko for blødning.
English: Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Danish: Analyse af alle dødsårsager viste ingen signifikant forskel mellem prasugrel og clopidogrel i den totale AKS-population (2,76 % mod 2,90 %), i UA/NSTEMIpopulationen (2.58 % mod 2.41 %) og i STEMI-populationen (3.28 % vs 4.31 %).
English: Your doctor will also tell you to take acetylsalicylic acid, and (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
Danish: Din læge vil ligeledes sige, at du skal tage acetylsalicylsyre samt fortælle dig den nøjagtige dosis, du skal tage (sædvanligvis mellem 75 mg og 325 mg daglig).
English: Approximately 40% of patients (in each of the treatment groups) received GP IIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Danish: Omkring 40 % af patienterne (i hver behandlingsgruppe) fik GP IIb/IIIa-inhibitorer til støtte for PCI (der er ingen tilgængelig information om den anvendte type af GP IIb/IIIa-inhibitor).
English: Mylan utca 1, Komárom, 2900, Hungary
Danish: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Ungarn
English: The usual dose of prasugrel is 10 mg per day.
Danish: Den sædvanlige dosis af prasugrel er 10 mg daglig.
English: This effect is likely to be of clinical concern only when prasugrel is co administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Danish: Denne virkning er sandsynligvis kun af klinisk interesse, når prasugrel administreres samtidig med lægemidler, hvor CYP2B6 er den eneste metaboliske vej, og hvor det terapeutiske vindue er smalt (f.eks. cyclophosphamid, efavirenz).
English: Overdose of Prasugrel Mylan may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Overdosering af Prasugrel Mylan kan medføre forlænget blødningstid og efterfølgende blødningskomplikationer.
English: It is important that you tell your doctor, dentist and pharmacist, that you are taking Prasugrel Mylan.
Danish: Det er vigtigt, at du fortæller din læge, tandlæge og på apotekspersonalet, at du tager Prasugrel Mylan.
English: Patients ≥75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events.
Danish: De patienter ≥ 75 år, hos hvem fordelen ved prasugrel var mest tydelig, omfattede dem med diabetes, STEMI, højere risiko for stenttromboser eller tilbagevendende hændelser.
English: The phase 3 TRITON study compared prasugrel with clopidogrel, both co-administered with ASA and other standard therapy.
Danish: Fase 3 TRITON-undersøgelsen sammenlignede prasugrel med clopidogrel, både administreret i kombination med ASA og anden standardterapi.
English: Concomitant administration of Prasugrel Mylan with coumarin derivatives other than warfarin has not been studied.
Danish: Administration af Prasugrel Mylan samtidig med andre kumarinderivater end warfarin er ikke blevet undersøgt.
English: Patients <60 kg
Danish: Patienter < 60 kg
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Danish: Farmakoterapeutisk klassifikation: Antithrombosemidler, blodplade-aggregationshæmmer eksklusive heparin, ATC-kode: B01AC22
English: There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (>75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Danish: Der var en øget incidens af tumorer (hepatocellulære adenomer) hos mus eksponeret gennem 2 år med høje doser (< 75 gange human eksponering), men dette blev betragtet sekundært til prasugrelinduceret enzyminduktion.
English: Prasugrel Mylan is to be administered concomitantly with acetylsalicylic acid (ASA).
Danish: Prasugrel Mylan er beregnet til at blive administreret samtidig med acetylsalicylsyre (ASA).
English: In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Danish: Hos raske forsøgspersoner og patienter er prasugrels farmakokinetik ens hos mænd og kvinder.
English: Medicinal products that elevate gastric pH
Danish: Lægemidler, som øger mavens pH
English: Each bottle contains a desiccant labelled “DO NOT EAT” and 28 or 30 film-coated tablets.
Danish: Hver beholder indeholder et tørremiddel mærket ”MÅ IKKE SPISES” og 28 eller 30 filmovertrukne tabletter.
English: Only take other medicines while you are on Prasugrel Mylan if your doctor tells you that you can.
Danish: Tag kun anden medicin, mens du får Prasugrel Mylan, hvis din læge siger, at du kan.
English: Oral use
Danish: Til oral anvendelse
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Prasugrel Mylan per day.
Danish: Hvis du vejer mindre end 60 kg eller er over 75 år, er daglig dosis 5 mg Prasugrel Mylan.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Therefore, the use of prasugrel in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Danish: Brugen af prasugrel til patienter med øget risiko for blødning bør derfor kun overvejes, når fordelene i form af forebyggelse af iskæmiske tilfælde vurderes at opveje risikoen for alvorlige blødninger.
English: Prasugrel Mylan can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Danish: Prasugrel Mylan kan administreres samtidig med lægemidler, som metaboliseres af cytokrom P450enzymer (inklusive statiner), eller lægemidler, som inducerer eller inhiberer cytokrom P450-enzymer.
English: If given together with Prasugrel Mylan these medicines may increase the risk of bleeding.
Danish: Hvis disse lægemidler tages sammen med Prasugrel Mylan, kan de øge risikoen for blødning.
English: If you then take Prasugrel Mylan and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.
Danish: Hvis du tager Prasugrel Mylan og derefter får allergiske reaktioner, som kendetegnes ved udslæt, kløe, hævelser i ansigtet, opsvulmede læber eller stakåndethed, skal du omgående fortælle det til din læge.
English: Non-fatal stroke
Danish: Ikke-letalt slagtilfælde
English: • ‘non-steroidal anti-inflammatory drugs' for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Danish: • ”et ikke-steroidt antiinflammatorisk middel” (såsom ibuprofen, naproxen og etoricoxib) mod smerte og feber.
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GP IIb/IIIa inhibitors, and stent type.
Danish: I den totale AKS-population var prasugrel forbundet med en lavere incidens af CV død, ikke-letale MI eller ikke-letale slagtilfælde sammenlignet med clopidogrel, uafhængigt af baselinekarakteristika såsom alder, køn, legemsvægt, geografisk region, brug af GP IIb/IIIa-inhibitorer og stenttype.
English: Inducers of cytochromes P450
Danish: Induktorer af P450 cytokromer
English: You have been prescribed Prasugrel Mylan because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Danish: Prasugrel Mylan er blevet ordineret til dig, fordi du allerede har haft et hjerteanfald eller ustabil hjertekrampe og fået en behandling for at åbne blokerede blodårer i hjertet.
English: Prasugrel Mylan is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Danish: Prasugrel Mylan er kontraindiceret til patienter med svært nedsat leverfunktion (Child Pugh klasse C).
English: These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, non-fatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Danish: Disse inkluderede endelig eller mulig stenttrombose ved forsøgets slutning (0,9 % mod 1,8 %, HR 0,498; CI 0,364, 0,683), CV død, ikkeletalt MI eller akut revaskularisering (urgent target vessel revascularisation)i løbet af 30 dage (5,9 % mod 7,4 %, HR 0,784, CI 0,688; 0,894), alle dødsfald, ikke-letalt MI eller ikke-letalt slagtilfælde til forsøgets afslutning (10,2 % mod 12,1 %, HR 0,831, CI 0,751, 0,919), CV død, ikke-letalt MI, ikkeletalt slagtilfælde eller genindlæggelse med iskæmisk hjertesygdom ved studiets afslutning (11,7 % mod 13,8 %, HR 0,831, CI 0,762; 0,921).
English: Analysis of the composite endpoint in the All ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p<0.05).
Danish: Analysen af det sammensatte endepunkt i den totale AKS-population (kombinerede UA/NSTEMI- og STEMI-kohorter) var betinget af en påvist statistisk forskel til fordel for prasugrel versus clopidogrel i UA/STEMI-kohorten (p < 0.05).
English: In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
Danish: Frekvensen af patienter, som i TRITON fik en ikke-CABG-relateret blødning, er vist i tabel 1.
English: Prasugrel Mylan can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Danish: Prasugrel Mylan kan ligeledes administreres samtidig med ASA, heparin, digoxin og lægemidler, som øger mavens pH, inklusive protonpumpehæmmere og H2-blokkere.
English: Medicinal products metabolised by CYP2C9
Danish: Lægemidler, som metaboliseres af CYP2C9
English: It is unknown whether prasugrel is excreted in human breast milk.
Danish: Det vides ikke, om prasugrel udskilles i modermælk hos mennesker.
English: Other therapies, such as heparin and GP IIb/IIIa inhibitors, were administered at the discretion of the physician.
Danish: Andre behandlinger såsom heparin og GPIIb/IIIainhibitorer blev administreret som skønnet af lægen.
English: You should show the doctor your pack of Prasugrel Mylan.
Danish: Du bør vise lægen pakken med Prasugrel Mylan.
English: Prasugrel showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3).
Danish: Sammenlignet med clopidogrel viste prasugral større effekt i reduktion af det primære sammensatte endepunkt såvel som det præspecificerede sekundære endepunkt, inklusive stenttrombose (se tabel 3).