FrancophonIA/ELRC3.0 huggingface dataset:
English: Nine cases (0.06%) of urticaria were reported in the Gardasil group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Danish: Der blev rapporteret ni tilfælde (0,06 %) af urticaria i Gardasil-gruppen og 20 tilfælde (0,15 %) i gruppen, der fik adjuvansholdigt placebo.
English: Common Pain in extremity Not known Arthralgia*, Myalgia*
Danish: Almindelig Smerter i ekstremiteter Ikke kendt Artralgi*, myalgi*
English: The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
Danish: GMT´erne var noget lavere end rapporteret i studier med ikke-hiv-inficerede forsøgspersoner på samme alder.
English: There were no treatmentrelated effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Danish: Der var ingen behandlingsrelaterede effekt på afkommets udvikling, opførsel, reproduktion eller fertilitet.
English: As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.
Danish: Som med enhver anden vaccine kan Gardasil ikke nødvendigvis beskytte 100 % af dem, der får vaccinen.
English: The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Danish: Vaccinen afstedkommer også produktion af typespecifikke antistoffer hos 9 til 15-årige børn og unge.
English: Persistence of Immune Response of Gardasil
Danish: Persistens af Gardasils immunrespons
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Danish: I 7 kliniske studier (6 placebo-kontrollerede) blev Gardasil eller placebo givet til personer på inklusionsdagen og cirka 2 og 6 måneder senere.
English: Immune Responses to Gardasil using a 2-dose schedule in individuals 9-13 years of age
Danish: Immunresponser på Gardasil ved brug af et program med 2 doser hos personer i alderen 9-13 år
English: Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
Danish: Gardasil kan som alle vacciner og medicin give bivirkninger, men ikke alle får bivirkninger.
English: The use of Gardasil in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Danish: Brugen af Gardasil hos voksne kvinder bør ske under hensyntagen til geografiske variationer i forekomsten af forskellige HPV-typer.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ubrugt eller overskydende materiale skal bortskaffes i overensstemmelse med lokal krav.
English: Immune Responses to Gardasil at 1 month post dose 3
Danish: Immunrespons over for Gardasil 1 måned efter 3. dosis
English: Table 3: Efficacy of Gardasil in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Danish: Tabel 3: Effekt af Gardasil imod high-grade cervixlæsioner i den modificerede ITT-population, der inkluderer kvinder uanset baseline HPV-status
English: How Gardasil is given
Danish: Sådan gives Gardasil
English: Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Danish: Gardasil indgives som en injektion gennem huden ind i musklen (helst en muskel i overarmen eller låret).
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Gardasil.
Danish: Dette er baseret på resultaterne fra et klinisk studie, hvor en kombineret TdaP-IPV-vaccine blev indgivet samtidig med den første dosis Gardasil (se pkt.
English: Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Danish: Ikke kendt Overfølsomhedsreaktioner, herunder anafylaktiske/anafylaktoide reaktioner*
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Gardasil used hormonal contraceptives during the vaccination period.
Danish: I kliniske studier brugte 57,5 % af kvinderne i alderen 16 til 26 år og 31,2 % af kvinderne i alderen 24 til 45 år, der fik Gardasil, hormonale kontraceptionsmidler i vaccinationsperioden.
English: Administration of Gardasil should be postponed in individuals suffering from an acute severe febrile illness.
Danish: Indgivelse af Gardasil skal udsættes hos personer, der lider af akut sygdom med feber.
English: Not known Idiopathic thrombocytopenic purpura*, lymphadenopathy*
Danish: Ikke kendt Idiopatisk trombocytopenisk purpura*, lymfadenopati*
English: Efficacy in women 24 through 45 years
Danish: Effekt hos kvinder fra 24 til 45 år
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”- see section 6).
Danish: • Hvis du eller dit barn er allergisk over for de aktive stoffer eller nogen af de øvrige indholdsstoffer i Gardasil (se pkt.
English: Gardasil was efficacious against HPV disease caused by each of the four vaccine HPV types.
Danish: Gardasil var effektiv mod HPV-sygdom forårsaget af hver af de fire vaccine-HPV-typer.
English: In a supplemental analysis, the efficacy of Gardasil was evaluated against HPV 16/18-related CIN 3 and AIS.
Danish: I en supplerende analyse blev Gardasils effekt mod HPV 16/18-relateret CIN 3 og AIS evalueret.
English: If you forget one dose of Gardasil:
Danish: Hvis du har glemt en vaccination med Gardasil:
English: Gardasil induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Danish: Gardasil fremkaldte høje anti-HPV geometriske middeltitre (GMT'er) én måned efter 3. dosis i alle testede aldersgrupper.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Danish: • Træk en 0,5 ml dosis af vaccinen ud af hætteglasset med en steril nål og sprøjte.
English: Intramuscular (IM) use.
Danish: Intramuskulær brug (i.m.)
English: Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.
Danish: Kvinder, som allerede var inficeret med en eller flere vaccinerelaterede HPV-typer forud for vaccination, var beskyttet imod klinisk sygdom forårsaget af de resterende vaccine-HPV-typer.
English: Furthermore, anti-HPV levels (GMTs) in vaccinated individuals remained at or above serostatus cut-off during the long-term followup of the Phase III studies (see below under Persistence of Immune Response of Gardasil).
Danish: Hertil kommer, at anti-HPV-niveauerne (GMT'er) hos vaccinerede personer forblev på eller over serostatus cut-off under langtidsopfølgningen i fase III-studierne (se afsnittet om ”Persistens af Gardasilsimmunrespons”).
English: Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Danish: Typespecifikke immunanalyser, kompetitiv Luminex-baseret immunanalyse (IgG-LIA) med typespecifikke standarder blev brugt til at vurdere immunogenicitet for hver af vaccinetyperne.
English: Gardasil is given as an injection by your doctor.
Danish: Gardasil gives af din læge som injektion.
English: Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Danish: Immunogenicitet var relateret til alder, og anti-HPV-niveauet ved måned 7 var signifikant højere hos unge personer.
English: When Gardasil is given as your first dose, the completion of the vaccination course should be done with Gardasil, and not with another HPV vaccine.
Danish: Hvis du får Gardasil som første dosis, skal vaccinationsforløbet fuldføres med Gardasil og ikke en anden HPV-vaccine.
English: GARDASIL administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Danish: GARDASIL indgivet til hanrotter med fuld human dosis (120 mikrogram total protein) havde ingen indflydelse på reproduktionsevne, herunder fertilitet, spermtal eller spermmotilitet og der var ingen betydelige vaccine-relaterede eller histomorfologiske ændringer i testiklerne og ingen effekt på testikelvægten.
English: types - genital warts (condyloma acuminata) causally related to specific HPV types.
Danish: - kondylomer (condyloma acuminata) kausalt relateret til specifikke HPV-typer.
English: Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Danish: Gardasil er udelukkende beregnet til profylaktisk anvendelse og har ingen effekt på aktive HPVinfektioner eller eksisterende klinisk sygdom.
English: The concomitant administration of Gardasil with vaccines other than the ones above has not been studied.
Danish: Samtidig indgivelse af Gardasil med andre vacciner end de herover anførte, er ikke blevet undersøgt.
English: At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3doses, n = 86) for all 4 HPV types.
Danish: Ved opfølgning ved måned 36 forblev GMT hos piger (2 doser, n=86) non-inferior til GMT hos kvinder (3 doser, n=86) for alle 4 HPV-typer.
English: Gardasil should be used in accordance with official guidelines.
Danish: Gardasil skal anvendes i overensstemmelse med officielle retningslinjer.
English: At end of study, individuals enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Danish: Ved studieafslutning blev de personer, der var rekrutteret til de to fase III-studier (protokol 013 og protokol 015), fulgt i op til 4 år (median 3,7 år).
English: Gardasil cannot cause the diseases it protects against.
Danish: Gardasil kan ikke forårsage de sygdomme, som vaccinen beskytter imod.
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Danish: Vaccinationen påvirkede ikke CD4% eller plasmahiv-RNA.
English: • Gardasil may appear as a clear liquid with a white precipitate prior to agitation.
Danish: • Gardasil kan fremstå som en klar væske med et hvidt præcipitat (bundfald) før omrystning.
English: The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs >10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Danish: Serobeskyttelsesforholdet (andelen af personer der når et serobeskyttende niveau antiHBs > 10 mIE/ml) var upåvirket (96,5 % ved samtidig vaccination, og 97,5 % ved hepatitis B vaccine alene).
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Danish: En mild infektion såsom mild øvre luftvejsinfektion eller let feber er dog ikke en kontraindikation for vaccination.
English: % of seropositive subjects n % of seropositive subjects
Danish: % af seropositive forsøgspersoner
English: Administration of Gardasil at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
Danish: Indgivelse af Gardasil samtidigt (men, i tilfælde af vacciner til injektion, på forskellige injektionssteder) med hepatitis B (rekombinant) vaccine forstyrrede ikke immunresponset over for HPV-typerne.
English: An academic study documenting safety and immunogenicity of Gardasil has been performed in 126 HIV infected subjects aged from 7-12 years (of which 96 received Gardasil).
Danish: Et studie, som dokumenterer Gardasils sikkerhed og immunogenicitet, blev gennemført med 126 hivinficerede forsøgspersoner i alderen fra 7 til12 år (hvoraf 96 fik Gardasil).
English: HIV infected subjects
Danish: Hiv-inficerede forsøgspersoner
English: The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents.
Danish: Indikationen er baseret på demonstration af Gardasils virkning hos kvinder i alderen 16-45 år og hos mænd i alderen 16-26 år og på demonstration af Gardasils immunogenicitet hos børn og unge i alderen 9-15 år.
English: The vaccine is therefore, not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Danish: Vaccinen er derfor ikke indiceret til behandling af cancer i livmoderhalsen, high-grade dysplastiske læsioner i cervix, vulva, vagina eller kondylomer.
English: There have been reports of administration of higher than recommended doses of Gardasil.
Danish: Der har været rapporter om, at der er indgivet flere doser af Gardasil end anbefalet.
English: Duration of protection of a 2-dose schedule of Gardasil has not been established.
Danish: Det vides ikke, hvor længe beskyttelsen varer efter et program med 2 doser Gardasil.
English: There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Gardasil and placebo treated individuals.
Danish: Der var ingen signifikant forskel i typen af medfødte misdannelser eller i hyppigheden af graviditeter med komplikationer hos personer, der fik Gardasil, og personer, der fik placebo.
English: As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients.
Danish: Ligesom med andre vacciner vil vaccination med Gardasil ikke nødvendigvis yde beskyttelse til alle vaccinemodtagere.
English: Bridging the Efficacy of Gardasil from Men to Boys
Danish: Gardasils effekt hos mænd overført til drenge
English: Table 2: Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population Gardasil
Danish: Tabel 2: Analyse af Gardasils effekt imod high-grade cervixlæsioner i PPE-populationen
English: In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.
Danish: Den bivirkningsprofil, der rapporteredes ved overdosering, var sammenlignelig med den, der blev set ved anbefalede enkeltdoser af Gardasil.
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, Acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Danish: Som for andre vacciner er der blevet rapporteret bivirkninger i forbindelse med brugen, herunder hævede lymfekirtler (hals, armhule eller lyske); muskelsvaghed, unormale fornemmelser, prikken i arme, ben og overkrop eller konfusion (Guillain-Barrés-syndrom, akut dissemineret encefalomyelitis); svimmelhed, opkastning, ledsmerter, ømme muskler, unormal træthedsfølelse eller svaghed, kuldegysninger, en generel følelse af utilpashed, blødning eller en øget tendens til at få blå mærker samt infektion i huden på injektionsstedet.
English: There are no safety, immunogenicity or efficacy data to support change during vaccination with Gardasil to other HPV vaccines which do not cover the same HPV types.
Danish: Der findes ingen data vedrørende sikkerhed, immunogenicitet eller effekt, der kan understøtte udskiftning af Gardasil med andre HPV-vacciner i løbet af vaccinationsprogrammet.
English: Gardasil does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination (see section 5.1).
Danish: Gardasil forebygger ikke læsioner, forårsaget af en vaccine-HPV-type, hos personer inficeret med denne HPV-type på vaccinationstidspunktet (se pkt.
English: (HPV 31/45) (HPV 31/33/45/52/58) 10 non-vaccine HPV Types HPV-16 related types (A9 species) HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 HPV-18 related types (A7 species) HPV 39 HPV 45 HPV 59 A5 species (HPV 51) A6 species (HPV 56)
Danish: (HPV 31/45) (HPV 31/33/45/52/58) 10 ikke-vaccine-HPV-typer HPV-16-relaterede typer (A9 arter) HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 HPV-18-relaterede typer ( A7 arter) HPV 39 HPV 45 HPV 59 A5 arter (HPV 51) A6 arter (HPV 56) Studierne var ikke designet til at vurdere effekt over for sygdom forårsaget af individuelle HPV-typer.
English: (95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
Danish: 100 % (95 % CI: 67,2; 100) og 100 % (95 % CI: 55,4; 100),
English: The use of Gardasil should be in accordance with official recommendations.
Danish: Gardasil bør anvendes i overensstemmelse med officielle anbefalinger.
English: Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Danish: Gardasil vil kun yde beskyttelse imod sygdomme, som skyldes HPV-typerne 6, 11, 16 og 18 og i en begrænset udstrækning imod sygdomme forårsaget af visse relaterede HPV-typer (se pkt.
English: After thorough agitation, it is a white, cloudy liquid.
Danish: Efter grundigt omrystning er den en hvid, uklar væske.
English: No minimum antibody level associated with protection has been identified for HPV vaccines.
Danish: Man har for HPV-vacciner ikke kunne identificere et minimums antistofniveau, som er associeret med beskyttelse.
English: Gardasil must not be injected intravascularly.
Danish: Gardasil må ikke injiceres intravaskulært.
English: B. PACKAGE LEAFLET (PREFILLED SYRINGE)
Danish: B. INDLÆGSSEDDEL (FYLDTE SPRØJTER)
English: In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 14 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
Danish: I disse studier var personer, der var seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16 og antiHPV 18 ved cLIA, stadig beskyttet mod klinisk sygdom efter opfølgning i 14 år for kvinder i alderen 16-23 år, 10 år for kvinder i alderen 24-45 år og 10 år for mænd i alderen 16-26 år.
English: Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate.
Danish: Før omrystning kan Gardasil fremstå som en klar væske med et hvidt bundfald.
English: Gardasil does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Danish: Gardasil har ingen effekt hos personer, som allerede har en infektion eller sygdom, der skyldes nogle af HPV-typerne i vaccinen.
English: Bridging the Efficacy of Gardasil from Women to Girls
Danish: Gardasils effekt hos kvinder overført på piger
English: The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Danish: Gardasils virkning over for CIN (af enhver grad) og CIN 2/3 eller AIS forårsaget af 10 ikke-vaccineHPV-typer (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59), der er strukturelt relateret til HPV 16 eller HPV 18, blev evalueret i den kombinerede fase III-effektdatabase (N = 17.599) efter en median opfølgningstid på 3,7 år (ved studieafslutning).
English: Table 1: Adverse Events Following Administration of Gardasil from Clinical Trials and PostMarketing Surveillance
Danish: Tabel 1: Bivirkninger efter indgivelse af Gardasil i kliniske studier og fra bivirkningsovervågning efter markedsføring.
English: The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 females 9 to 45 years of age and 3,093 males 9 to 26 years of age at enrolment) who received Gardasil and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
Danish: De personer, der blev monitoreret ved hjælp af vaccinationsrapporteringskort, omfattede 10.088 personer (6.995 kvinder i alderen 9 til 45 år og 3.093 mænd i alderen 9 til 26 år på rekrutteringstidspunktet), der fik Gardasil, og 7.995 personer (5.692 kvinder og 2.303 mænd), der fik placebo.
English: 1 dose, 0.5 ml.
Danish: 1 dosis, 0,5 ml.
English: Assays to Measure Immune Response
Danish: Analyser til måling af immunrespons
English: Discard the vaccine if particulates are present and/or if it appears discoloured.
Danish: Bortskaf vaccinen, hvis der er partikler i den, og/eller hvis den fremstår misfarvet.
English: {MM/YYYY}
Danish: CI: 92,3; 98,2),
English: Gardasil produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16-45 years of age and in men 16-26 years of age.
Danish: Gardasil afstedkommer produktion af type-specifikke antistoffer og har i kliniske studier vist sig at kunne forebygge HPV 6-, 11-, 16-, og 18-relaterede sygdomme hos kvinder i alderen 16-45 år og hos mænd i alderen 16-26 år.
English: Three clinical studies (Protocols 016, 018 and 020) were used to compare the immunogenicity of Gardasil in 9- to 15-year-old boys to 16- to 26-year-old men.
Danish: Tre kliniske studier (Protokollerne 016, 018 og 020) blev brugt til at sammenligne Gardasils immunogenicitet hos 9-15-årige drenge med den, der sås hos 16-26-årige mænd.
English: However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil can still protect against diseases associated with the other HPV types in the vaccine.
Danish: Hos personer, som allerede er inficeret med en eller flere af de HPV-typer, der indgår i vaccinen, kan Gardasil dog stadig forebygge sygdomme, som skyldes de andre HPV-typer, som vaccinen beskytter imod.
English: A clinical study (Protocol 016) compared the immunogenicity of Gardasil in 10- to 15-year-old girls to those in 16- to 23 year old women.
Danish: Et klinisk studie (Protokol 016) sammenlignede Gardasils immunogenicitet i 10- til 15-årige piger, med den der sås i 16- til 23-årige kvinder.
English: At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Gardasil (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Gardasil (at 0, 2, 6 months).
Danish: I per protokol-populationen var immunresponset hos piger i alderen 9-13 år (n=241), som fik 2 doser Gardasil (ved måned 0 og 6) ved måned 7 non-inferiort til og numerisk højere end immunresponset hos kvinder i alderen 16-26 år (n=246), som fik 3 doser Gardasil (ved måned 0, 2 og 6).
English: When Gardasil was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.
Danish: Når Gardasil blev givet sammen med en kombineret difteri, tetanus, pertussis [acellulær, komponent] og poliomyelitis [inaktiveret] boostervaccine under det samme besøg, var hovedpine og hævelser på injektionsstedet hyppigere.
English: Common Nausea Not known Vomiting*
Danish: Almindelig Kvalme Ikke kendt Opkastning*
English: Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Danish: Gardasil inducerede et specifikt antistofrespons mod HPV-type 6, 11, 16 og 18 i drægtige rotter efter en eller flere intramuskulære injektioner.
English: The impact of Gardasil against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Danish: Gardasils indflydelse på den overordnede risiko for eksterne genitale læsioner blev evalueret efter den første dosis hos 2.545 personer rekrutteret i fase III-effektstudiet (Protokol 020).