FrancophonIA/ELRC3.0 huggingface dataset:
English: 27/28 patients with genotype 4 HCV achieved SVR12.
Danish: 27/28 patienter med genotype 4 HCV opnåede SVR12.
English: Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Danish: Infektioner og parasitære sygdomme: Almindelig nasofaryngitis Blod og lymfesystem:
English: Patients were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3.
Danish: Patienterne fik enten ikke antiretroviral behandling med et CD4+ celletal på > 500 celler/mm3, eller de havde virologisk supprimeret hiv-1 med et CD4+ celletal > 200 celler/mm3.
English: This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted.
Danish: Disse data indikerer, at nyreclearance er den største eliminationsvej for GS-331007, hvor en stor del secerneres aktivt.
English: • getting a cold (nasopharyngitis)
Danish: • forkølelse (nasofaryngitis)
English: The difference in the overall SVR12 rates between sofosbuvir + ribavirin and peginterferon alfa + ribavirin treatment groups was 0.3% (95% confidence interval: -7.5% to 8.0%) and the study met the predefined non-inferiority criterion.
Danish: Forskellen i de samlede SVR12-rater mellem behandlingsgrupperne med sofosbuvir + ribavirin og peginterferon alfa + ribavirin var 0,3 % (95 % konfidensinterval: -7,5 % til 8,0 %), og studiet opfyldte det prædefinerede kriterium for non-inferioritet.
English: If any of the side effects get serious tell your doctor.
Danish: Hvis nogle af bivirkningerne bliver alvorlige, skal du fortælle det til lægen.
English: TN = treatment-naïve; TE = treatment-experienced.
Danish: TN = behandlingsnaive, TE = behandlingserfarne.
English: The recommended dose is one tablet (400 mg) once a day with food.
Danish: Den anbefalede dosis er én tablet (400 mg) én gang dagligt sammen med mad.
English: Post-baseline NS5B sequences were available for 225 of the 226 patients, with deep sequencing data (assay cutoff of 1%) from 221 of these patients.
Danish: NS5B-sekvenser efter baseline var tilgængelige for 225 ud af de 226 patienter, med dybe sekvensdata (afskæring for analyse på 1 %) for 221 af disse patienter.
English: The safety and efficacy of Sovaldi in children and adolescents aged <12 years have not yet been established.
Danish: Sovaldis sikkerhed og virkning hos børn og unge i alderen < 12 år er endnu ikke klarlagt.
English: Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis
Danish: Samlet Genotype 1a Genotype 1b Uden cirrose Cirrose
English: • severe headaches (migraine), memory loss, loss of concentration
Danish: • alvorlige hovedpiner (migræne), hukommelsestab, manglende koncentration
English: The virologic response rates of the 41 patients transplanted with HCV RNA <LLOQ is described in Table 19.
Danish: De virologiske responsrater for de første 41 patienter, der blev transplanteret med HCV-rna < LLOQ er beskrevet i tabel 19.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Danish: Samtidig anvendelse af amiodaron blev begrænset ved den kliniske udvikling af sofosbuvir.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales tæt overvågning af patienterne ved initiering af behandlingen med Sovaldi.
English: The duration of administration of Sovaldi in patients awaiting liver transplantation should be guided by an assessment of the potential benefits and risks for the individual patient (see section 5.1).
Danish: Behandlingsvarigheden med Sovaldi til patienter, der venter på levertransplantation, skal fastsættes under hensyntagen til en vurdering af de mulige fordele og risici for den individuelle patient (se pkt.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite ranged from 8 to 28 times higher than the clinical exposure at 400 mg sofosbuvir.
Danish: I rottestudierne kunne eksponeringen for sofosbuvir ikke bestemmes, men eksponeringsmarginer baseret på den primære humane metabolit var i intervallet fra 8 til 28 gange højere end den kliniske eksponering ved 400 mg sofosbuvir.
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Danish: ORALE ANTIKONTRACEPTIVA Norgestimat/ethinylestradiol Norgestromin
English: • and you notice 18 hours or more after the time you usually take Sovaldi, wait and take the next dose at your usual time.
Danish: • og du opdager det 18 timer eller længere efter det tidspunkt, du normalt tager Sovaldi, skal du vente og tage den næste dosis på det sædvanlige tidspunkt.
English: A single subject with genotype 5 and all 6 patients with genotype 6 HCV infection in this study achieved SVR12.
Danish: En enkelt person med genotype 5 og alle 6 patienter med genotype 6 HCV-infektion i dette studie opnåede SVR12.
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Danish: Filmovertræk: Polyvinylalkohol, titandioxid, macrogol 3350, talcum, gul jernoxid.
English: If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this medicinal product, the peginterferon alfa dose should be reduced or discontinued.
Danish: Hvis sofosbuvir anvendes i kombination med peginterferon alfa, og en patient har en alvorlig bivirkning, som muligvis er relateret til dette lægemiddel, skal dosis af peginterferon alfa reduceres eller seponeres.
English: Following treatment with sofosbuvir 200 mg or 400 mg in combination with ribavirin the SVR12 rate in patients with ESRD was 40% and 60%, respectively.
Danish: Efter behandling med sofosbuvir 200 mg eller 400 mg kombineret med ribavirin var SVR12-raten hos patienter med ESRD henholdsvis 40 % og 60 %.
English: These recommendations are based on the absorption kinetics of sofosbuvir and GS-331007 suggesting that the majority of the dose is absorbed within 2 hours after dosing.
Danish: Disse anbefalinger er baseret på absorptionskinetikken af sofosbuvir og GS-331007, som tyder på, at hovedparten af dosis absorberes inden for 2 timer efter dosering.
English: Such co-administration is not recommended.
Danish: Samtidig administration anbefales ikke.
English: The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
Danish: Den primære, inaktive cirkulerende metabolit, GS-331007, der udgør over 90 % af lægemiddel-relateret systemisk eksponering, dannes via sekventielle og parallelle veje til dannelsen af den aktive metabolit.
English: Pregnancy must be avoided due to the use of Sovaldi together with ribavirin.
Danish: En graviditet skal undgås når Sovaldi anvendes sammen med ribavirin.
English: Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Danish: Site-dirigeret mutagenese af S282T-substitutionen i replikoner fra 8 genotyper tildelte 2 til 18 gange nedsat følsomhed over for sofosbuvir, og reducerede den viral replikationskapacitet med 89 % til 99 %, sammenlignet med den tilhørende vildtype.
English: Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Danish: Mikrokrystallinsk cellulose (E460(i)) Croscarmellosenatrium Kolloid vandfri silica (E551) Magnesiumstearat (E470b)
English: SVR12 to SVR24 concordance
Danish: SVR12 til SVR24 overensstemmelse
English: Common alopecia, dry skin, pruritus alopecia, dry skin
Danish: Almindelig alopeci, tør hud, pruritus alopeci, tør hud
English: Severe RI (eGFR
Danish: Mildt RI (eGFR
English: Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Danish: Sofosbuvir er et substrat for lægemiddeltransporteren P-gp og brystcancer-resistent protein (BCRP), hvorimod GS-331007 ikke er det.
English: • and you notice within 18 hours of the time you usually take Sovaldi, you must take the tablet as soon as possible.
Danish: • og du opdager det inden for 18 timer fra det tidspunkt, du normalt tager Sovaldi, skal du tage tabletten snarest muligt.
English: • low white blood cell count (neutropenia); the signs may include getting more infections than usual, including fevers and chills, or sore throat or mouth ulcers
Danish: • lavt antal hvide blodlegemer (neutropeni); tegnene kan omfatte flere infektioner end normalt, herunder feber og kulderystelser, eller ondt i halsen eller sår i munden
English: Until liver transplantationc
Danish: Indtil levertransplantationc
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years.
Danish: Sovaldi indeholder det aktive stof sofosbuvir, som gives til behandling af infektion med hepatitis Cvirus hos voksne og unge i alderen 12 år op til 18 år.
English: Treatment-experienced (FUSION)
Danish: Behandlingserfarne (FUSION)
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Danish: To patienter havde cirrose ved baseline, og den gennemsnitlige eGFR var 24,9 ml/min (interval: 9,0-39,6).
English: The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure (see section 5.2).
Danish: Udgangsstoffet sofosbuvir udgør ca. 4 % af systemisk eksponering for det lægemiddel-relaterede materiale (se pkt.
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Danish: Pyreksi, asteni brystsmerter, asteni a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
English: The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063).
Danish: Sikkerheden af sofosbuvir i en fast dosiskombination med enten ledipasvir eller velpatasvir er blevet undersøgt hos 154 patienter med ESRD, som krævede dialyse (Studie 4062 and Studie 4063).
English: If the starting dose of ribavirin is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels (see section 5.1).
Danish: Hvis startdosis af ribavirin ikke er veltolereret, bør dosis reduceres efter klinisk indikation, baseret på hæmoglobinniveau (se pkt.
English: Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to increase exposures of medicinal products that are substrates of these transporters.
Danish: Sofosbuvir og GS-331007 er ikke hæmmere af P-gp og BCRP, og de forventes derfor ikke at øge eksponeringen af lægemidler, der er substrater for disse transportere.
English: Tacrolimuse (5 mg single dose)
Danish: Tacrolimuse (5 mg enkeltdosis)
English: The concordance between SVR12 and SVR24 (SVR 24 weeks after the end of the treatment) following treatment with sofosbuvir in combination with ribavirin or ribavirin and pegylated interferon demonstrates a positive predictive value of 99% and a negative predictive value of 99%.
Danish: Overensstemmelsen mellem SVR12 og SVR24 (SVR 24 uger efter afsluttet behandling) efter behandling med sofosbuvir i kombination med ribavirin eller ribavirin samt pegyleret interferon viser en positiv prædiktiv værdi på 99 %, og en negativ prædiktiv værdi på 99 %.
English: * The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.
Danish: * Den daglige dosis ribavirin er vægtbaseret og fordeles på to daglige doser, som administreres oralt sammen mad.
English: Genotype 2 and 3 patients were either treatment-naïve or experienced, whereas genotype 1 patients were naïve to prior treatment.
Danish: Patienter med genotype 2 og 3 var enten behandlingsnaive eller -erfarne, hvorimod patienter med genotype 1 var naive før behandlingen.
English: Of the seven patients who did not achieve SVR12, none experienced virologic failure or relapsed.
Danish: Ud af de syv patienter, som ikke opnåede SVR12, oplevede ingen virologisk svigt eller recidiv.
English: Placebo 12 weeks (n = 71)
Danish: Placebo 12 uger (n = 71)
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sovaldi.
Danish: På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med Sovaldi.
English: One patient with genotype 3 HCV infection achieved SVR4 but did not return for the SVR12 visit.
Danish: Én patient med genotype 3 HCVinfektion opnåede SVR4, men kom ikke tilbage til SVR12-besøget.
English: Tell your doctor if you have kidney problems or if you are on kidney dialysis.
Danish: Fortæl lægen, hvis du har nyreproblemer eller er i dialyse.
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Danish: GS-331007 fjernes effektivt ved hæmodialyse med et ekstraktionsforhold på cirka 53 %.
English: The recommended treatment regimen and durations for Sovaldi combination therapy are provided in Table 3 and Table 4.
Danish: Det anbefalede behandlingsregime og de anbefalede behandlingsvarigheder for Sovaldi kombinationsbehandling findes i tabel 3 og tabel 4.
English: Refer to the ribavirin prescribing information for guidance on dose modification or discontinuation.
Danish: Se ordinationsoplysninger for ribavirin for vejledning om modifikation eller seponering.
English: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 patients) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Danish: I studie 0126 var fald i hæmoglobin i løbet af behandlingen meget almindelig, og 32,5 % (13/40 patienter) oplevede et fald i hæmoglobin til < 10 g/dl, hvoraf 1 havde et fald til < 8,5 g/dl.
English: Patients had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Danish: Patienterne havde HCV-rna ≥ 104 IE/ml ved screening og dokumenteret evidens for kronisk HCV-infektion inden transplantationen.
English: Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Sovaldi.
Danish: Se også produktresuméerne for de lægemidler, der anvendes i kombination med Sovaldi.
English: Common depression depression, anxiety, agitation
Danish: Almindelig depression depression, angst, ophidselse
English: Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
Danish: Sofosbuvir er et nukleotid prodrug, der metaboliseres i udstrakt grad.
English: If you forget to take Sovaldi
Danish: Hvis du har glemt at tage Sovaldi
English: Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
Danish: Patienter, som også tager betablokkere, eller patienter med underliggende kardielle komorbiditeter og/eller fremskreden leversygdom kan være i øget risiko for symptomatisk bradykardi ved samtidig administration af amiodaron.
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Danish: Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 3350 (E1521) Talcum (E553b) Gul jernoxid (E172)
English: However, based on emerging data, the study was unblinded and all HCV genotype 2 patients continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 patients was extended to 24 weeks.
Danish: Baseret på opdukkende data blev studiet imidlertid afblindet, og alle HCV-genotype 2-patienter fortsatte med at få sofosbuvir og ribavirin i 12 uger, mens behandlingen for HCV-genotype 3-patienter blev forlænget til 24 uger.
English: Adult liver transplant recipients - Study 0126
Danish: Voksne patienter, der har gennemgået en levertransplantation - studie 0126
English: The tablet should be taken with food (see section 5.2).
Danish: Tabletten bør tages sammen med mad (se pkt.
English: When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Danish: Når du tager Sovaldi sammen med ribavirin eller både peginterferon alfa og ribavirin, kan du få en eller flere af de nedenstående bivirkninger:
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Danish: SVR-raterne for grupperne, som fik 8, 12 og 24 ugers behandling med ledipasvir/sofosbuvir var henholdsvis 93 % (42/45), 100 % (31/31) og 79 % (15/19).
English: There are no data to support the co-administration of Sovaldi and telaprevir or boceprevir.
Danish: Der er ingen data til at støtte administration af Sovaldi sammen med telaprevir eller boceprevir.
English: Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side.
Danish: Gul, kapselformet, filmovertrukket tablet med dimensionerne 20 mm x 9 mm, præget på den ene side med “GSI” og med “7977” på den anden side.
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Danish: Defosforylering fører til dannelse af nukleosidmetabolitten GS-331007, der ikke kan refosforyleres effektivt, og som mangler anti-HCVaktivitet in vitro.
English: No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Danish: Der kræves ingen dosisjustering af Sovaldi for patienter med let, moderat eller svært nedsat leverfunktion (Child-Pugh-Turcotte [CPT] klasse A, B eller C) (se pkt.
English: This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Danish: Denne patient havde < 1 % HCV S282T ved baseline, og udviklede S282T (> 99 %) 4 uger efter behandlingen, hvilket resulterede i en 13,5gange ændring i EC50 for sofosbuvir og en reduceret viral replikationskapacitet.
English: • Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Danish: • Carbamazepin, phenobarbital og phenytoin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Danish: Sofosbuvir og GS-331007 AUC'er er næsten dosisproportionale over doseringsintervallet fra 200 mg til 400 mg.
English: Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Danish: Mannitol, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid, vandfri silica, magnesiumstearat.
English: The ribavirin doses used in the sofosbuvir + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1,000-1,200 mg/day and 800 mg/day regardless of weight, respectively.
Danish: Ribavirin doserne, der blev anvendt i armene med sofosbuvir + ribavirin og peginterferon alfa 2a + ribavirin var hhv. vægtbaserede 1.000-1.200 mg/dag samt 800 mg/dag uanset vægt.
English: The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Danish: De kliniske data til at støtte anvendelsen af Sovaldi hos patienter med HCV-genotype 5 og 6-infektion er meget begrænset (se pkt.
English: • hair loss and thinning hair
Danish: • hårtab og og tyndhåret
English: GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Danish: GS-461203 (den aktive metabolit af sofosbuvir) er ikke en hæmmer af humane dna- og rna-polymeraser, eller en hæmmer af mitokondriel rna-polymerase.
English: Response rates for patients with cirrhosis at baseline are presented in Table 10 by HCV genotype.
Danish: Responsraterne for patienter med cirrose ved baseline er vist i tabel 10 efter HCV-genotype.
English: Sovaldi 400 mg film-coated tablets
Danish: Sovaldi 400 mg filmovertrukne tabletter
English: Thus, the optimal treatment duration in this population has not been established (see also sections 4.2 and 5.1).
Danish: Derfor er den optimale behandlingsvarighed for denne population ikke klarlagt (se også pkt.
English: Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Danish: Hæmodialyse er effektivt til at fjerne (53 % ekstraktionsforhold) den dominerende cirkulerende metabolit, GS-331007.
English: • low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
Danish: • lavt antal røde blodlegemer (anæmi); tegnene kan omfatte træthedsfølelse, hovedpiner, stakåndethed, når der dyrkes motion
English: Duration of viral suppression prior to transplantation was the most predictive factor for pTVR in those who were HCV RNA <LLOQ at the time of transplantation.
Danish: Varigheden af viral suppression før transplantation var den bedste prædiktive faktor for pTVR hos de patienter, der havde HCV-rna < LLOQ på tidspunktet for transplantationen.
English: Sovaldi should be used in combination with other medicinal products.
Danish: Sovaldi bør anvendes i kombination med andre lægemidler.
English: The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours respectively.
Danish: De gennemsnitlige terminale halveringstider for sofosbuvir og GS-331007 var hhv. 0,4 og 27 timer.
English: Mean ratio (90% confidence interval) for
Danish: Gennemsnitligt forhold (90 % konfidensinterval)
English: The adverse reactions observed were consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults (see Table 6).
Danish: De observerede bivirkninger var i overensstemmelse med bivirkninger observeret i kliniske studier med Sovaldi plus ribavirin hos voksne (se tabel 6).
English: In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response.
Danish: Desuden blev der detekteret S282R- og L320F-substitutioner under behandling med dybe sekvensdata hos en patient før transplantation med et delvist behandlingsrespons.
English: If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.2).
Danish: Hvis de andre lægemidler, der anvendes i kombination med Sovaldi, seponeres permanent, skal Sovaldi også seponeres (se pkt.
English: Table 3: Recommended treatment regimen and durations for adolescents aged 12 to < 18 years treated with Sovaldi
Danish: Tabel 3: Anbefalet behandlingsregime og -varighed for unge i alderen 12 til <18 år, der behandles med Sovaldi
English: Sovaldi tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Danish: Sovaldi tabletter leveres i tabletbeholdere af højdensitets polyethylen (HDPE) med et børnesikret lukke af polypropylen, som indeholder 28 filmovertrukne tabletter med et tørremiddel af silicagel og en polyesterspiral.
English: In patients that discontinued therapy at 24 weeks, according to protocol, the relapse rate was 11/15.
Danish: Hos patienter, der fik seponeret behandlingen efter 24 uger, i henhold til protokollen, var recidivraten