FrancophonIA/ELRC3.0 huggingface dataset:
English: **Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable
Danish: **Tilbagefaldsraten var den andel af forsøgspersonerne, der havde ikke-detekterbart hcv-RNA ved afslutning af behandlingen (EOT) og detekterbart hcv-RNA ved afslutning af follow-up-perioden (EOF) blandt de forsøgspersoner, som var ikke-detekterbare ved EOT, og hvor der ikke manglede EOF-data.
English: Diarrhoea*, nausea*, vomiting* dry mouth, dysgeusia Abdominal pain*, abdominal pain upper*, constipation*, gastrooesophageal reflux disease*, haemorrhoids*, abdominal discomfort, abdominal distention, anorectal discomfort, aphthous stomatitis, cheilitis, dyspepsia, flatulence, glossodynia, mouth ulceration, oral pain, stomatitis, tooth disorder
Danish: Diarré*, kvalme*, opkastning*, tør mund, dysgeusi Mavesmerter*, smerter i øvre abdomen*, obstipation*, gastroøsofageal reflukssygdom*, hæmorrider*, mavegener, oppustet mave, anorektalt ubehag, aftøs stomatitis, keilitis, dyspepsi, flatulens, glossodyni, mundulceration, oral smerte, stomatitis, tandlidelser Smerter i nedre abdomen*, gastritis*, pancreatitis*, analpruritus, colitis, dysfagi, misfarvet fæces, hyppige tarmbevægelser, gingival blødning, gingivale smerter, gingivitis, glossitis, tørre læber, odynofagi, proktalgi, rektal blødning, hypersekretion af spyt, følsomhed i tænder, tungemisfarvning, tungeulceration Pancreas-insuffiens
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist because
Danish: Er du i tvivl, så spørg lægen eller
English: tacrolimus AUC ↑ 1610% tacrolimus Cmax ↑ 890%
Danish: ↑ 233 % maraviroc C12t ↑ 178 %
English: Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing EOF data.
Danish: Tilbagefaldsraten var mængden af forsøgspersoner med ikke-detekterbart hcv-RNA ved behandlingsafslutning (EOT) og detekterbart hcv-RNA ved afslutning af opfølgningsperioden (EOF) blandt forsøgspersoner, der ikke var detekterbare ved EOT og som ikke manglede EOF-data.
English: General disorders and administration site conditions Asthenia*, chills, fatigue*, pyrexia*, influenza-like
Danish: Asteni*, kuldegysninger, træthed*, pyreksi*, influenzalignende sygdom
English: Lead-In Response (Viral Load Reduction)
Danish: respons (virusmængdereduktion)
English: {MM/YYYY}
Danish: RGT).
English: (tacrolimus 0.5 mg single dose + Victrelis 800 mg three times daily multiple doses)
Danish: Digoxin* (0,25 mg digoxin enkeltdosis + Victrelis 800 mg tre gange dagligt)
English: Hypoaesthesia*, paraesthesia*, syncope*, amnesia, disturbance in attention, memory impairment, migraine, parosmia, tremour, vertigo
Danish: Hypoæstesi*, paræstesi*, synkope*, amnesi, opmærksomhedsforstyrrelser, hukommelsessvækkelse, migræne, parosmi, tremor, svimmelhed Perifer neuropati*, cognitive forstyrrelser, hyperæstesi, apati, tab af bevidsthed, svækkelse, neuralgi,
English: Victrelis in combination with peginterferon alfa and ribavirin is not recommended in patients who
Danish: Victrelis i kombination med peginterferon alfa og ribavirin bør ikke anvendes til patienter, som har et trombocyttal <100.000/mm
English: Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as
Danish: Komplet blodtælling (med leukocytdifferentialtælling) skal foreligge før behandlingsstart og i behandlingsuge 2, 4, 8 og 12 og skal monitoreres tæt på andre tidspunkter,
English: Relapsers
Danish: Hæmolyse
English: *** Null responder: subject who had less than a 2-log10 HCV-RNA decline by treatment week 12 with
Danish: *** Null-responder: forsøgsperson, som havde et hcv-RNA-fald, der var mindre end 2-log10, i behandlingsuge 12 med peginterferon alfa-2b og ribavirin.
English: Eye disorders Common:
Danish: Det endokrine system Almindelig:
English: 1 plasma HCV-RNA at
Danish: 1 plasma hcv-RNA i behandlingsuge 24.
English: Musculoskeletal chest pain*, arthritis, bone pain, joint swelling, musculoskeletal pain
Danish: Rygsmerter*, ekstremitetssmerter*, muskelspasmer, muskelsvækkelse, nakkesmerter Muskuloskeletale brystsmerter*, arthritis, knoglesmerter, ledhævelser, muskuloskeletale smerter
English: lopinavir AUC ↓ 34% lopinavir Cmax ↓ 30% lopinavir Cmin ↓ 43%
Danish: etravirin AUC ↓ 23 % etravirin Cmaks.
English: Use in patients with rare hereditary disorders
Danish: Brug hos patienter med sjældne arvelige sygdomme Victrelis indeholder lactose.
English: Tacrolimus* (tacrolimus 0.5 mg single dose + Victrelis 800 mg single dose)
Danish: Sirolimus*(sirolimus 2 mg enkeltdosis + Victrelis 800 mg 3 gange dagligt)
English: Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.
Danish: Komplet blodtælling (med leukocytdifferentialtælling) skal foreligge før behandlingsstart og i behandlingsuge 2, 4, 8 og 12 og skal monitoreres tæt på andre tidspunkter, når det er klinisk relevant.
English: Age
Danish: Tal
English: HCV Relapse Rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable
Danish: Tilbagefaldsraten for hcv var mængden af forsøgspersoner med ikke-detekterbart hcv-RNA ved behandlingsafslutning (EOT) og detekterbart hcv-RNA ved afslutning af opfølgningsperioden (EOF) blandt forsøgspersoner, der ikke var detekterbare ved EOT og som ikke manglede EOF-data.
English: Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Danish: Rater for vedvarende virologisk respons (SVR)*, afslutning af behandling (EOT) og tilbagefald hos forsøgspersoner, hvor tidligere behandling har svigtet Tilbagefald † i det primære studie
English: To obtain the hard capsules the foil of the blister should be peeled off. Victrelis is to be taken orally with food (a meal or light snack).
Danish: For at udtage de hårde kapsler skal blisterfolien fjernes.
English: Mechanism of action
Danish: *Seponerings-regler
English: Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, 12 and should be monitored closely at other time points, as clinically appropriate.
Danish: Komplet blodtælling (med leukocytdifferentialtælling) skal foreligge før behandlingsstart og i behandlingsuge 2, 4, 8, 12 og skal udføres ofte på andre tidspunkter, når det er klinisk relevant.
English: Adverse Reactions
Danish: Resistens
English: Not studied
Danish: Der er ikke udført interaktionsundersøgelser
English: Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable at
Danish: Tilbagefaldsraten var andelen af forsøgspersoner med ikke-detekterbart hcv-RNA ved behandlingsafslutning (EOT) og detekterbart hcv-RNA ved afslutning af opfølgningsperioden (EOF) blandt de forsøgspersoner, som var ikke-detekterbare ved EOT, og hvor der ikke manglede EOF
English: drospirenone AUC ↑ 99% drospirenone Cmax ↑ 57%
Danish: digoxin AUC ↑ 19 % digoxin Cmaks.
English: boceprevir AUC ↑ 131% boceprevir Cmax ↑ 41% boceprevir Cmin N/A
Danish: boceprevir AUC ↑ 10 % boceprevir Cmaks.
English: The proposal was rejected by the majority of CVMP members.
Danish: Forslaget blev afvist af et flertal af medlemmerne af CVMP.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, hvor referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Østrig, Belgien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Luxembourg, Nederlandene, Norge, Polen, Portugal, Slovakiet, Spanien og Sverige.
English: The opinion was converted into a Decision by the European Commission on 22 July 2010.
Danish: Udtalelsen blev konverteret til en afgørelse truffet af Europa-Kommissionen den 22. juli 2010.
English: The Mutual Recognition Procedure UK/V/0321/001/MR started on 1 May 2008.
Danish: Den gensidige anerkendelsesprocedure UK/V/0321/001/MR blev indledt den 1. maj 2008.
English: Given that no absolute majority was attained, the opinion of 15 July 2009 stands.
Danish: Da der ikke blev opnået et absolut flertal, forbliver udtalelsen af 15. juli 2009 gældende.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II.
English: Article 33(4) of Directive 2001/82/EC, as amended.
Danish: 1 Artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: On 4 November 2008, the United Kingdom, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Belgium and Sweden, that the efficacy of the product has not been sufficiently demonstrated.
Danish: Den 4. november 2008 indbragte Det Forenede Kongerige sagen for agenturet i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, eftersom Belgien og Sverige havde udtrykt bekymring for, at der ikke var fremlagt tilstrækkelig dokumentation for produktets virkning.
English: The referral procedure started on 12 November 2008.
Danish: Indbringelsesproceduren blev indledt den 12. november 2008.
English: Oral explanations were given on 16 June 2009.
Danish: Der blev afgivet mundtlige redegørelser den 16. juni 2009.
English: The Rapporteur and Co-Rapporteur appointed were: Prof. Christian Friis and Dr Valda Sejane, respectively.
Danish: Som rapportør og medrapportør udpegedes: Prof. Christian Friis og dr. Valda Sejane (i den rækkefølge).
English: Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy.
Danish: På grundlag af vurderingen af rapportørens bedømmelse af de aktuelt tilgængelige data var CVMP af den opfattelse, at ansøgningen ikke opfylder kriterierne for godkendelse for så vidt angår virkning.
English: The detailed grounds for the re-examination were submitted by CEVA Animal Health Ltd on 21 September 2009 and the re-examination procedure started on 22 September 2009.
Danish: De detaljerede begrundelser for revurderingen blev fremlagt af CEVA Animal Health Ltd den 21. september 2009, og revurderingsproceduren blev indledt den 22. september 2009.
English: During its 15-17 September 2009 meeting, the CVMP appointed Dr David Murphy as rapporteur and Dr Jiří Bureš as co-rapporteur for the re-examination of the above mentioned opinion.
Danish: CVMP udpegede på sit møde den 15.-17. september 2009 dr. David Murphy som rapportør og dr. Jiří Bureš som medrapportør for revurderingen af ovennævnte udtalelse.
English: On 5 August 2009, CEVA Animal Health Ltd notified the Agency of its intention to request a reexamination of the CVMP opinion of 15 July 2009.
Danish: Den 5. august 2009 meddelte CEVA Animal Health Ltd agenturet, at virksomheden havde til hensigt at anmode om en revurdering af CVMP's udtalelse af 15. juli 2009.
English: Written explanations were provided by the Applicant on 16 February 2009.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 16. februar 2009.
English: Therefore, the Committee adopted an opinion on 15 July 2009 recommending the suspension of the existing marketing authorisation and the refusal of the granting of the marketing authorisations for Tildren 500 mg, lyophilisate for solution for infusion.
Danish: Derfor vedtog udvalget den 15. juni 2009 en udtalelse, der anbefaler suspendering af den eksisterende markedsføringstilladelse og afslag på ansøgningen om markedsføringstilladelse for Tildren 500 mg, lyofilisat til infusionsvæske, opløsning.
English: Tiludronic acid as the disodium salt, is a synthetic derivative of pyrophosphate belonging to the class of biphosphonates.
Danish: Tiludronsyre i form af dinatriumsalt er et syntetisk derivat af pyrophosphat, som tilhører klassen af bisphosphonater.
English: Based on the evaluation of the rapporteurs' assessment of the detailed grounds for the re-examination, on 11 November 2009, the CVMP considered the rapporteurs' proposal for amending the opinion adopted on 15 July 2009.
Danish: På grundlag af vurderingen af rapportørens bedømmelse af de detaljerede begrundelser for revurderingen drøftede CVMP den 11. november 2009 rapportørens forslag til ændring af udtalelsen af 15. juli 2009.
English: The marketing authorisation holder, CEVA Animal Health Ltd, submitted an application for a mutual recognition procedure for TILDREN 500 mg, lyophilisate for solution for infusion, on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen, CEVA Animal Health Ltd, indgav ansøgning om en gensidig anerkendelsesprocedure for TILDREN 500 mg, lyofilisat til infusionsvæske, opløsning, på grundlag af den markedsføringstilladelse, Det Forenede Kongerige har udstedt.
English: TILDREN 500 mg, lyophilisate for solution for infusion is a veterinary medicinal product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age.
Danish: TILDREN 500 mg, lyofilisat til infusionsvæske, opløsning, er et lægemiddel til dyr, der indiceres som en hjælp i behandlingen af de kliniske tegn på halten i forbindelse med benspat kombineret med et kontrolleret motionsprogram hos heste på over tre år
English: The infusion may last up to 30 minutes.
Danish: Infusionen kan vare op til 30 minutter.
English: Proper aseptic technique must be observed.
Danish: Passende aseptisk teknik skal iagttages.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel skal præparatet anvendes straks.
English: Use of gloves and other protective equipment is recommended.
Danish: Det anbefales at bære handsker og andet beskyttelsesudstyr.
English: As this medicine is being given by a doctor or nurse, it is unlikely that you will be given too much.
Danish: Da dette lægemiddel gives af en læge eller sygeplejerske, er det usandsynligt, at du vil få for meget.
English: Conditions you need to look out for
Danish: Tilstande, du skal holde øje med
English: These reactions can occur immediately following or up to 24 hours after administration of Kyprolis.
Danish: Disse reaktioner kan opstå straks eller op til 24 timer efter administration af Kyprolis.
English: Your doctor will examine you and review your full medical history.
Danish: Din læge vil undersøge dig og gennemgå hele din sygehistorie.
English: • Any other major disease for which you were hospitalised or received any medicine.
Danish: • Enhver anden betydelig sygdom, du har været indlagt for eller fået en hvilken som helst medicin for.
English: You may also be given other medicines.
Danish: Du vil muligvis også få anden medicin.
English: You will be monitored closely during treatment.
Danish: Du vil blive overvåget nøje under behandlingen.
English: Most patients will receive treatment for as long as their disease improves or remains stable.
Danish: De fleste patienter vil få behandlingen, så længe deres sygdom bedres eller forbliver stabil.
English: The elapsed time from reconstitution to administration should not exceed 24 hours.
Danish: Tiden fra rekonstitution til administration må ikke overstige 24 timer.
English: Cycle 2 and all subsequent cycles
Danish: Cyklus 2 og alle efterfølgende cylkusser
English: Some of these events have been fatal.
Danish: Nogle af disse hændelser var dødelige.
English: The proteasome is a system within the cells that breaks down proteins when they are damaged or no longer needed.
Danish: Proteasomer er et system inde i cellerne, der nedbryder proteiner, når de er ødelagte eller ikke længere nødvendige.
English: Do not drive a car or operate machines if you have these symptoms.
Danish: Lad være med at køre motorkøretøj eller betjene maskiner, hvis du har disse symptomer.
English: Elderly patients (≥ 75 years)
Danish: Ældre patienter (≥ 75 år)
English: The median follow-up was approximately 37 months.
Danish: Medianopfølgningen var cirka 37 måneder.
English: Increased c-reactive protein
Danish: Forhøjet C-reaktivt protein
English: Oral and/or intravenous hydration should be continued, as needed, in subsequent cycles.
Danish: Oral og/eller intravenøs hydrering skal fortsætte efter behov i de efterfølgende cyklusser.
English: Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis.
Danish: Dexamethason skal administreres 30 minutter til 4 timer inden Kyprolis.
English: Your doctor will check you for signs of this infection before, during and for some time after treatment with this medicine.
Danish: Din læge vil undersøge dig for tegn på denne infektion før, under og i et stykke tid efter behandlingen med dette lægemiddel.
English: Kyprolis will be stored in the pharmacy.
Danish: Kyprolis vil blive opbevaret på apoteket.
English: The median follow-up was approximately 67 months.
Danish: Medianopfølgningen var cirka 67 måneder.
English: There is currently insufficient information to draw conclusions about the safety of doses higher than those evaluated in clinical studies.
Danish: Der er aktuelt ikke tilstrækkelig information til at drage nogen konklusioner om sikkerheden ved doser, som er højere end de doser, der er undersøgt i kliniske studier.
English: Evaluate as appropriate.
Danish: Evaluér efter behov.
English: Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment.
Danish: Kyprolis gives 2 dage i træk hver uge i 3 uger efterfulgt af en enkelt uge uden behandling.
English: These patients may be at greater risk for cardiac complications.
Danish: Sådanne patienter kan have en øget risiko for hjertekomplikationer.
English: Tell your doctor if you have ever had or might now have a hepatitis B infection.
Danish: Fortæl det til lægen, hvis du på noget tidspunkt har haft eller muligvis nu har en hepatitis B-infektion.
English: The marketing authorisation holder shall submit the first PSUR for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: Tell your doctor straight away if you get notice any of the following symptoms:
Danish: Fortæl det straks til lægen, hvis du bemærker et eller flere af følgende symptomer:
English: This study did not evaluate the benefit/risk ratio in the broader refractory population.
Danish: Studiet evaluerede ikke benefit/risk-forholdet i den bredere population af refraktære patienter.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser efter åbning brugerens eget ansvar og bør ikke overstige 24 timer ved 2 °C - 8 °C.
English: • Allergic reaction to Kyprolis
Danish: • Allergisk reaktion på Kyprolis
English: • A general feeling of illness or discomfort
Danish: • En generel følelse af sygdom eller utilpashed
English: Remove vial from refrigerator just prior to use.
Danish: Tag hætteglasset ud af køleskabet umiddelbart inden brug.
English: This assessment should optimise the patient's status, with particular attention to blood pressure control and fluid management.
Danish: Denne vurdering bør optimere patientens status med særlig fokus på blodtrykskontrol og væskekontrol.
English: Your doctor or nurse will determine the dose of Kyprolis that you receive.
Danish: Lægen eller sygeplejersken vil fastlægge den dosis Kyprolis, du skal have.
English: By preventing the breakdown of proteins in cancer cells, which are more likely to contain more abnormal proteins, Kyprolis causes the death of cancer cells.
Danish: Ved at forhindre nedbrydningen af proteiner i kræftceller, som med større sandsynlighed indeholder flere unormale proteiner, medfører Kyprolis, at kræftcellerne dør.
English: If PML is suspected, further administration must be suspended until PML has been excluded by a specialist with appropriate diagnostic testing.
Danish: Hvis der er mistanke om PML, skal yderligere administration afbrydes, indtil PML er blevet udelukket af en specialist ved hjælp af relevante diagnostiske test.
English: If you are given too much Kyprolis
Danish: Hvis du har fået for meget Kyprolis
English: Subsequently patients should be treated with caution and remain under close follow-up.
Danish: Efterfølgende skal patienten behandles med forsigtighed og hele tiden følges nøje.
English: Each pack contains 1 vial.
Danish: Hver pakning indeholder 1 hætteglas.
English: a. Study PX-171-009
Danish: a. Studie PX-171-009
English: If you had these symptoms prior to treatment with carfilzomib, tell your doctor about any change in these symptoms.
Danish: Hvis du havde disse symptomer før behandling med carfilzomib, skal du fortælle lægen om eventuelle ændringer i disse symptomer.
English: The dose will be calculated based on your height and weight (body surface area).
Danish: Dosis vil blive beregnet på baggrund af din højde og vægt (legemsoverfladearealet).
English: • Stop until resolved or returned to baseline
Danish: • Stop, indtil det er svundet eller returneret til baseline-niveau
English: These may all be symptoms of a serious and potentially fatal brain condition known as Progressive Multifocal Leukoencephalopathy (PML).
Danish: Disse kan alle være symptomer på en alvorlig og potentielt dødelig hjernesygdom, der kaldes for progressiv multifokal leukoencefalopati (PML).
English: White to off-white lyophilised powder.
Danish: Hvidt til offwhite lyofiliseret pulver.
English: Proportion Surviving without Progression
Danish: Andel overlevende uden progression
English: You must read the package leaflet of all medicines that you take in combination with Kyprolis so that you understand the information related to those medicines.
Danish: Du skal læse indlægssedlerne til alle de lægemidler, du tager i kombination med Kyprolis, så du forstår de informationer, der vedrører disse lægemidler.
English: Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia).
Danish: Der skal træffes foranstaltninger for at forsøge at minimere alle risikofaktorer, der kan ændres (fx rygning, hypertension og hyperlipidæmi).
English: • Serum creatinine equal to or greater than 2 × baseline; or
Danish: • Serumkreatinin lig med eller større end 2 × baseline, eller
English: They should be monitored for clinical and laboratory signs of HBV reactivation during and after the end of treatment.
Danish: De skal monitoreres for kliniske og laboratoriemæssige tegn på reaktivering af HBV under og efter ophør af behandlingen.
English: If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Danish: Hvis lenalidomid tages under graviditet, forventes en teratogen virkning af lenalidomid hos mennesker.
English: Kyprolis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Danish: Kyprolis bør ikke anvendes under graviditet, medmindre den potentielle fordel opvejer den potentielle risiko for fosteret.
English: The results of study 2011-003 are summarised in table 7.
Danish: Resultaterne af studie 2011-003 er opsummeret i tabel 7.