FrancophonIA/ELRC3.0 huggingface dataset:
English: Cimzia can be taken together with: methotrexate, corticosteroids, or pain medicines including nonsteroidal anti-inflammatory medicines (also called NSAIDs).
Danish: Cimzia kan bruges samtidig med: - methotrexat, - kortikosteroider, eller - smertestillende medicin, herunder non-steroide antiinflammatoriske stoffer (også kaldet
English: • lupus (immune/connective tissue disease) symptoms (joint pain, skin rashes, photosensitivity and fever)
Danish: • lupus (immun-/bindevævssygdom)-symptomer (ledsmerter, hududslæt, lysfølsomhed og feber)
English: At the end of this period the dose-dispenser cartridges must be used or discarded.
Danish: Ved afslutningen af denne periode skal kassetterne til dosisdispenser bruges eller kasseres.
English: fever, headache and rash)
Danish: feber, hovedpine og udslæt)
English: If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
Danish: Hvis din læge afgør, at behandling med methotrexat er uhensigtsmæssig, kan Cimzia gives alene.
English: In the placebo group, 52% of patients experienced no radiographic progression (mTSS ≤ 0.0) at Week 52 compared to 69% in the Cimzia 200 mg treatment group.
Danish: I placebogruppen oplevede 52% af patienterne ikke radiografisk progression (mTSS ≤ 0,0) i uge 52 sammenlignet med 69% i behandlingsgruppen, som fik 200 mg Cimzia.
English: Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.
Danish: Tilfælde af forværret kronisk hjerteinsufficiens er også rapporteret hos patienter med reumatoid artritis i behandling med Cimzia.
English: Rare seizure, cranial nerve inflammation, impaired coordination or balance
Danish: Sjælden kramper, inflammation i kranienerverne, påvirket koordination eller balance
English: Table 10 Key efficacy outcomes in PsA001 clinical trial (percent of patients) Response
Danish: Tabel 10 Vigtige effektresultater i det kliniske studie PsA001 (procentdel af patienter) Respons
English: At week 16, patients randomized to Cimzia who achieved a PASI 50 response continued to receive Cimzia up to Week 48 at the same randomized dose.
Danish: I uge 16 fortsatte patienter, der var randomiseret til Cimzia og som opnåede en PASI 50 respons, med at få Cimzia op til uge 48 med samme randomiserede dosis.
English: In the pivotal studies, for subjects who were ANA negative at baseline, 16.7% of those treated with Cimzia developed positive ANA titers, compared with 12.0% of subjects in the placebo group.
Danish: I de pivotale studier for personer som var ANA-negative ved baseline udviklede 16,7% af dem, som blev behandlet med Cimzia, positive ANA-titer sammenlignet med 12% af personerne i placebogruppen.
English: At Week 52, a statistically significant greater proportion of patients treated with Cimzia achieved ASDAS-MI response compared to patients treated with placebo.
Danish: Ved uge 52 havde en statistisk signifikant større andel af patienterne behandlet med Cimzia opnået ASDAS-MI-respons sammenlignet med patienterne behandlet med placebo.
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et eksplorativt klinisk studie, hvor brugen af en anden TNF-antagonist, infliximab, blev undersøgt hos patienter med moderat til alvorlig kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter hos patienter behandlet med infliximab end hos kontrolpatienter, hovedsageligt i lunger eller hoved og hals.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least 1 occasion was 9.6% in RA placebo-controlled trials.
Danish: Den samlede andel af patienter med antistoffer mod Cimzia, som kunne påvises mindst én gang, var 9,6% i de placebokontrollerede RA-studier.
English: In the placebo+MTX group, 49.7% of patients experienced no radiographic progression (change in mTSS ≤0.5) at Week 52 compared to 70.3% in the Cimzia+MTX group (p<0.001).
Danish: I placebo+MTX-gruppen oplevede 49,7% af patienterne ikke radiografisk progression (ændring i mTSS ≤ 0,5) ved uge 52 sammenlignet med 70,3% i Cimzia+MTX-gruppen (p< 0,001).
English: • inflammatory skin rash (erythema multiforme)
Danish: • betændt hududslæt (erythema multiforme)
English: Table 5 Changes over 12 months in RA-I Placebo + MTX N=199 Mean (SD)
Danish: Tabel 5 Ændringer over 12 måneder i RA-I Placebo + MTX N=199 Gennemsnitlig (SD)
English: Patients with an inadequate response at Week 16 (PASI 50 non-responders) were eligible to receive Cimzia 400 mg every 2 weeks until Week 48 in an open label manner.
Danish: Patienter med en utilstrækkelig respons i uge 16 (PASI 50 non-respondenter) var egnet til at få Cimzia 400 mg hver 2. uge indtil uge 48 på en ikkeblindet måde.
English: In clinical trials with Cimzia and other TNF-antagonists, more cases of lymphoma and other malignancies have been reported among patients receiving TNF-antagonists than in control patients receiving placebo (see section 4.8).
Danish: I kliniske studier med Cimzia og andre TNF-antagonister blev der rapporteret om flere tilfælde af lymfomer og andre maligniteter blandt de patienter, som fik TNF-antagonister, end hos kontrolpatienter, som fik placebo (se pkt.
English: Do not remove the needle cap. - “Medication accepted” is shown if it is correct.
Danish: - ”Medicin accepteret” vises, hvis den er korrekt.
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol (see section 4.8).
Danish: Der er rapporteret om melanom og Merkelcellekarcinom hos patienter, der har fået TNF-antagonister, herunder certolizumab pegol (se pkt.
English: Always take the Patient Reminder Card with you.
Danish: Tag altid patient-påmindelseskortet med dig.
English: No dose recommendations can be made (see section 5.2).
Danish: Der kan ikke gives dosisanbefalinger (se pkt.
English: • Choose a site on your thighs or tummy.
Danish: • Vælg et sted på låret eller maven.
English: For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate.
Danish: Ved reumatoid artritis og psoriasisartritis bør behandling med MTX fortsættes under behandlingen med Cimzia, hvis det er hensigtsmæssigt.
English: • With one quick, short motion, push the needle all the way into the skin.
Danish: • Pres nålen med en hurtig, kort bevægelse helt ind i huden.
English: Your doctor should test you for HBV before starting Cimzia.
Danish: Din læge vil teste dig for HBV, før behandling med Cimzia påbegyndes.
English: • symptoms of blood disorders such as persistent fever, bruising, bleeding, paleness
Danish: • symptomer på blodsygdomme, såsom vedvarende feber, blå mærker, blødning, bleghed
English: Excluding non-melanoma skin cancer, 9 malignancies including 1 case of lymphoma were observed in the Cimzia psoriasis clinical trials in which a total of 1112 patients were treated, representing 1481 patient-years.
Danish: Bortset fra ikke-melanom hudkræft, blev der observeret 9 maligniteter, herunder 1 tilfælde af lymfom, i de kliniske studier med Cimzia-psoriasis, hvor i alt 1112 patienter blev behandlet, repræsenterende 1481 patient-år.
English: • gastrointestinal cancer, melanoma
Danish: • kræft i mave-tarm-kanalen, melanom
English: Serious infections, including sepsis and tuberculosis (including miliary, disseminated and extrapulmonary disease), and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia.
Danish: Alvorlige infektioner, inklusive sepsis og tuberkulose (inklusive miliær, dissemineret og ekstrapulmonal sygdom) og andre opputunistiske infektioner (f.eks. histoplasmose, nocardia, candidiasis) er rapporteret hos patienter, som fik Cimzia.
English: • Any unused product(s) or waste material should be disposed of in accordance with local requirements.
Danish: • Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Danish: Sikkerhedsprofilen hos patienter med psoriasisartritis, som blev behandlet med Cimzia, svarede til sikkerhedsprofilen hos patienter med reumatoid artritis samt tidligere erfaringer med Cimzia.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de udvikler sygdomstegn/symptomer, der tyder på bloddyskrasi eller infektion (f.eks. vedvarende feber, øget tendens til blå mærker, blødning, bleghed), under behandling med Cimzia.
English: If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject the next dose of Cimzia as soon as you remember.
Danish: Hvis lægen har ladet dig injicere dig selv, og du glemmer at tage en injektion, skal du injicere den næste dosis af Cimzia, så snart du kommer i tanke om det.
English: • eye and eyelid inflammation, vision disturbances, problems with tears
Danish: • betændelse i øjne eller øjenlåg, synsforstyrrelser, problemer med tårer
English: Uncommo sepsis (including multi-organ failure, septic shock), tuberculosis (including miliary, disseminated and extrapulmonary disease), fungal infections (includes opportunistic)
Danish: Ikke almindelig sepsis (inklusive multiorgansvigt, septisk shock), tuberkulose (inklusive miliær, dissemineret og ekstrapulmonal sygdom), svampeinfektioner (inklusive opportunistiske)
English: • oedema (swelling in the face or legs)
Danish: • ødemer (hævelser i ansigtet eller benene)
English: • Allow the medication to reach room temperature.
Danish: • Lad medicinen opnå stuetemperatur.
English: • serious skin rashes.
Danish: • alvorligt hududslæt.
English: • allergic conditions including allergic rhinitis and allergic reactions to the medicine (including anaphylactic shock)
Danish: • allergiske tilstande, herunder allergisk snue og allergiske reaktioner over for lægemidlet
English: In PsA001 clinical trial, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp score (mTSS) and its components, the Erosion Score (ES) and Joint Space Narrowing score (JSN) at Week 24, compared to baseline.
Danish: I det kliniske studie PsA001 blev hæmningen af den progressive strukturelle ødelæggelse vurderet radiografisk og udtrykt som ændringen i modified total Sharp score (mTSS) og dennes komponenter, erosionsscore (ES) og score for forsnævring af ledspalter (JNS) ved uge 24 sammenlignet med baseline.
English: At the end of this period the pre-filled syringes must be used or discarded.
Danish: Ved afslutningen af denne periode skal de fyldte sprøjter bruges eller kasseres.
English: Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region) (see section 5.3).
Danish: Prækliniske studier antyder, at et homologt Fab-fragment af certolizumab pegol (ingen Fc-region) i lav eller ubetydelig grad overføres via placenta (se pkt.
English: Mean decreases (improvements) in DLQI from baseline ranged from -8.9 to -11.1 with Cimzia 200 mg every 2 weeks, from -9.6 to -10.0 with Cimzia 400 mg every 2 weeks, versus -2.9 to -3.3 for placebo at Week 16.
Danish: Gennemsnitlige reduktioner (forbedringer) i DLQI i forhold til baseline var mellem8,9 og -11,1 med Cimzia 200 mg hver 2. uge, mellem -9,6 og -10,0 med Cimzia 400 mg hver 2 uge, versus mellem -2,9 og -3,3 for placebo i uge 16.
English: You will be given Cimzia as either one (200 mg dose) or two injections (400 mg dose) under the skin (subcutaneous use, abbreviation: SC).
Danish: Cimzia indgives som enten én (200 mg dosis) eller to injektioner (400 mg dosis) under huden (subkutan brug, forkortelse s.c.).
English: Uncommo anaemia, lymphadenopathy, thrombocytopaenia, thrombocytosis
Danish: Ikke almindelig anæmi, lymfadenopati, thrombocytopeni, thrombocytose
English: Injecting the solution subcutaneously with air bubbles is harmless.
Danish: Subkutan injicering af injektionsvæske med luftbobler er uskadelig.
English: Medication: dose-dispenser cartridge
Danish: Medicin: kassette til dosisdispenser
English: For both the Cimzia and placebo arms, MTX was initiated as of Week 0 (10 mg/week), titrated up to maximum tolerated dose by Week 8 (min 15 mg/week, max 25 mg/week allowed), and maintained throughout the study (average dose of MTX after Week 8 for placebo and Cimzia was 22.3 mg/week and 21.1 mg/week respectively).
Danish: I både placebo- og Cimzia-armen blev MTX initieret ved uge 0 (10 mg/uge), optitreret til den maksimalt tolererede dosis ved uge 8 (minimum 15 mg/uge, maksimalt tilladt 25 mg/uge) og opretholdt under hele studiet (gennemsnitlig MTX-dosis efter uge 8 var 22,3 mg/uge og 21,1 mg/uge for placebo- henholdsvis Cimzia-armen).
English: Sodium acetate Sodium chloride Water for injections
Danish: Natriumacetat Natriumchlorid Vand til injektionsvæsker
English: Cimzia treatment inhibited the radiographic progression compared with placebo treatment at Week 24 as measured by change from baseline in total mTSS Score (LS mean [±SE] score was 0.28 [±0.07] in the placebo group compared with 0.06 [±0.06] in the Cimzia all doses group; p=0.007).
Danish: Behandling med Cimzia viste signifikant mindre radiografisk progression sammenlignet med placebo ved uge 24, målt ved ændringer fra baseline i total mTSS (LS (mindste kvadrat) gennemsnit [±SE] score var 0,28 [±0,07] i placebogruppen sammenlignet med 0,06 [±0,06] i de 2 Cimzia-grupper; p=0,007).
English: All subjects who did not achieve a PASI 75 response at Week 16 entered an escape arm and received Cimzia 400 mg every 2 weeks.
Danish: Alle forsøgspersoner, der ikke opnåede en PASI 75 respons i uge 16, indgik i en særgruppe og fik Cimzia 400 mg hver 2. uge.
English: These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Danish: Disse kan vise sig som rødlige målskivelignende pletter eller runde områder ofte med centrale blærer på overkroppen, skællende hud, sår i mund, hals, næse, kønsorganer og øjne som kan komme efter forudgående feber og influenzalignende symptomer.
English: The impact of long-term treatment with Cimzia on the development of autoimmune diseases is unknown.
Danish: Indvirkningen på udviklingen af autoimmune sygdomme ved langtidsbehandling med Cimzia er ikke kendt.
English: The frequency was increased both in patients treated with placebo (2.8% vs 0.4% in axSpA and RA populations, respectively) as well as in patients treated with Cimzia (4.7% vs 0.8% in axSpA and RA populations, respectively).
Danish: Frekvensen var højere både hos patienter, der blev behandlet med placebo (henholdsvis 2,8% hos patienter med axSpA vs. 0,4% hos patienter med RA), og hos patienter, som blev behandlet med Cimzia (henholdsvis 4,7% hos patienter med axSpA vs. 0,8% hos patienter med RA).
English: If you forget to use Cimzia
Danish: Hvis du har glemt at bruge Cimzia
English: Cimzia is used in adults for the following inflammatory diseases:
Danish: Cimzia anvendes til voksne ved følgende inflammatoriske sygdomme (sygdomme med betændelseslignende reaktioner):
English: Cimzia-treated patients had a statistically significant higher ACR 20 response rate at Week 12 and Week 24 compared with placebo-treated patients (p<0.001).
Danish: Patienter behandlet med Cimzia havde en signifikant højere ACR20-responsrate ved uge 12 og uge 24 sammenlignet med patienter, som fik placebo (p< 0,001).
English: The recommended starting dose of Cimzia for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4.
Danish: Den anbefalede startdosis til voksne patienter er 400 mg Cimzia (givet som 2 subkutane injektioner a 200 mg) ved uge 0, 2 og 4.
English: • viral infections (including cold sores, shingles, and influenza)
Danish: • virusinfektioner (herunder forkølelsessår, helvedesild og influenza)
English: Among patients remaining in the study, who had both baseline values and week 204 values, inhibition of inflammatory signs in both the sacroiliac joints (n=72) and spine (n=82) was largely maintained through Week 204 in the overall axial spondyloarthritis population as well as in both the AS and the nr-axSpA subpopulations.
Danish: Hos de patienter, som forblev i studiet, og som havde både baseline-værdier og uge 204-værdier, blev der i høj grad opretholdt hæmning af inflammatoriske tegn både i sacroiliacaleddene (n=72) og i rygsøjlen (n=82) til og med uge 204 i den samlede aksiale spondyloartritis-population samt i subpopulatonerne med ankyloserende spondylitis og nonradiografisk aksial spondyloartritis.
English: The safety profile of Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks were generally similar.
Danish: Sikkerhedsprofilen for Cimzia 400 mg hver 2. uge og Cimzia 200 mg hver 2. uge var generelt sammenlignelig.
English: Comprehensive instructions for the preparation and administration of Cimzia in a dose-dispenser cartridge are given in the package leaflet and in the user manual provided with the electromechanical injection device ava.
Danish: Detaljeret vejledning til tilberedning og administrering af Cimzia i en kassette til dosisdispenser er givet i indlægssedlen og i brugermanualen, som udleveres sammen med den elektromekaniske injektionsanordning ava.
English: At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo.
Danish: Ved uge 12 og uge 24 var procentdelen af patienter med ASAS40-respons højere i de grupper, som fik Cimzia, sammenlignet med placebo.
English: Among 273 patients initially randomised to Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks, 237 (86.8%) were still on this treatment at Week 48.
Danish: Blandt de 273 patienter, som ved behandlingsstart var randomiseret til 200 mg Cimzia hver 2. uge og 400 mg Cimzia hver 4. uge, fik 237 (86,8%) stadig denne behandling ved uge 48.
English: Do NOT use Cimzia - If you are ALLERGIC (hypersensitive) to certolizumab pegol or any of the other ingredients of this medicine (listed in section 6) - If you have a severe infection, including active TUBERCULOSIS (TB).
Danish: Brug IKKE Cimzia - Hvis du er ALLERGISK over for certolizumab pegol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 4.4% in the AS001 phase III placebo controlled trial in patients with axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations).
Danish: Den samlede procentdel af patienter med antistoffer mod Cimzia, påvist mindst én gang frem til uge 24, var 4,4% i det placebokontrollerede fase III-studie AS001 hos patienter med aksial spondyloartritis (ankyloserende spondylitis og non-radiografisk aksial spondyloartritis subpopulationer).
English: • some blood parameters increased (blood alkaline phosphatase increased)
Danish: • forhøjede blodværdier (forhøjet indhold af basisk fosfatase i blodet)
English: Please read the instructions at the end of this leaflet on how to inject Cimzia and in the user manual provided with the injection device ava.
Danish: Læs venligst vejledningen om hvordan Cimzia injiceres i slutningen af denne indlægsseddel og i brugermanualen, som udleveres sammen med injektionsanordningen ava.
English: • lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Danish: • Lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne)
English: Patients originally randomized to placebo that achieved a PASI 50 response but not a PASI 75 response at Week 16 received Cimzia 200 mg every 2 weeks (with a loading dose of Cimzia 400 mg at Weeks 16, 18, and 20).
Danish: Patienter, der oprindeligt blev randomiseret til placebo, og som opnåede en PASI 50 respons, men ikke en PASI 75 respons i uge 16, fik Cimzia 200 mg hver 2. uge (med en støddosis Cimzia på 400 mg i uge 16, 18 og 20).
English: Check the medicine in the body of the syringe.
Danish: Kontroller medicinen i sprøjten.
English: ACR 50 p-value*
Danish: ACR50 p-værdi*
English: Check the medicine through the medication body.
Danish: Kontroller medicinen ved at se gennem medicinens hoveddel.
English: Antibody formation was associated with lowered drug plasma concentration.
Danish: Antistofdannelse var forbundet med nedsat lægemiddelkoncentration i plasma.
English: ACR 70 p-value*
Danish: ACR70 p-værdi*
English: If you stop using Cimzia
Danish: Hvis du holder op med at bruge Cimzia
English: For administration, the instructions for use at the end of the package leaflet and in the user manual provided with the electromechanical injection device ava should be followed.
Danish: Administrationsvejledningen givet til sidst i indlægssedlen og i brugermanualen, som udleveres sammen med den elektromekaniske injektionsanordning ava, bør følges.
English: However, these are insufficient with respect to human reproductive toxicity (see section 5.3).
Danish: Dog er disse dyrestudier ikke tilstrækkelige med hensyn til reproduktionstoksicitet hos mennesker (se pkt.
English: • Push plunger head all the way down until the entire dose has been given and the plunger head is between the needle guard activation clips.
Danish: • Pres stemplet helt ned, indtil hele dosen er injiceret, og stempelhovedet står mellem de 2
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er opført efter aftagende alvorlighedsgrad inden for hver frekvensgruppe.
English: Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
Danish: Voksne med svær, aktiv aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation påvist ved forhøjet C-reaktivt protein (CRP) og/eller ved magnetisk resonans scanning (MRI), og som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: • nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation,
Danish: • nervesygdomme i ekstremiteterne, herunder symptomer på følelsesløshed, snurren, brændende fornemmelse, svimmelhed, skælven
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Danish: Efter markedsføring er der rapporteret tilfælde af leukæmi hos patienter behandlet med en TNF-antagonist.
English: Patients originally randomized to Cimzia who achieved a PASI75 response at Week 16 were rerandomized based on their original dosing schedule.
Danish: Patienter, der oprindeligt blev randomiseret til Cimzia, og som opnåede en PASI 75 respons i uge 16, blev genrandomiseret på basis af deres oprindelige doseringsplan.
English: The total content (1 ml) of the pre-filled pen should be administered as a subcutaneous injection only.
Danish: Hele indholdet (1 ml) i den fyldte pen bør udelukkende administreres som subkutan injektion.
English: Sustained remission* (DAS28(ESR) <2.6 at both Week 40 and Week 52) Sustained low disease activity (DAS28(ESR) ≤3.2 at both Week 40 and Week 52) *Primary endpoint of C-EARLY trial (to Week 52) Full analysis set, non-responder imputation for missing values.
Danish: Vedvarende lav sygdomsaktivitet (DAS28(ESR) ≤ 3,2 både ved uge 40 og uge 52) *Primært endepunkt i C-EARLY-studiet (til uge 52) Komplet analysesæt, manglende værdier tillægges status som ikke-respondent.