FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is two inhalations of Trimbow twice daily.
Slovenian: Priporočeni odmerek sta dve inhalaciji zdravila Trimbow dvakrat na dan.
English: The maximum dose is two inhalations of Trimbow twice daily.
Slovenian: Največji odmerek sta dve inhalaciji zdravila Trimbow dvakrat na dan.
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trimbow
Slovenian: 1 Neželeni učinki, poročani v povzetku glavnih značilnosti zdravila za vsaj eno od posamičnih sestavin, ki pa jih niso opazili med neželenimi učinki v kliničnem razvoju zdravila Trimbow
English: If any of the above applies to you, tell your doctor before you use Trimbow.
Slovenian: Če karkoli od navedenega velja za vas, obvestite zdravnika, preden začnete uporabljati zdravilo
English: Infants and neonates born to mothers receiving substantial doses of Trimbow should be observed for adrenal suppression.
Slovenian: Pri dojenčkih in novorojenčkih, rojenim materam, ki so prejele večje odmerke zdravila Trimbow, je treba zato spremljati pojav zaviranja nadledvičnih žlez.
English: Trimbow should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Slovenian: Uporabo zdravila Trimbow je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je to potrebno.
English: The use of Trimbow with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Slovenian: Učinek nastavka Uporaba zdravila Trimbow z nastavkom AeroChamber Plus pri bolnikih s KOPB je povečala v pljučih doseženo količino beklometazon 17-monopropionata, formoterola in glikopironija (največja koncentracija v plazmi se je povečala za 15 %, 58 % oz. 60 %).
English: If this occurs you should stop using Trimbow and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Slovenian: Če se to zgodi, prenehajte uporabljati zdravilo Trimbow in nemudoma uporabite hitrodelujoči "inhalator z olajševalcem", da boste obvladali kratko sapo in piskajoče dihanje.
English: Trimbow should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Slovenian: Zdravilo Trimbow se lahko med nosečnostjo uporablja le, če so pričakovane koristi za mater večje od možnega tveganja za zarodek.
English: Trimbow can be used at the recommended dose in patients with mild to moderate renal impairment.
Slovenian: Zdravilo Trimbow se lahko uporablja v priporočenem odmerku pri bolnikih z blago do zmerno okvaro ledvic.
English: An overdose of Trimbow may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Slovenian: Preveliko odmerjanje zdravila Trimbow lahko povzroči znake in simptome zaradi delovanja posamičnih sestavin, vključno s tistimi, ki se pojavijo pri prevelikem odmerjanju drugih agonistov adrenergičnih receptorjev beta2 ali antiholinergikov in so skladni z znanimi učinki razreda inhalacijskih kortikosteroidov (glejte poglavje 4.4).
English: Do not stop using Trimbow or lower the dose, even if you are feeling better or you have no symptoms.
Slovenian: Pomembno je, da zdravilo Trimbow uporabljate vsak dan. Ne prenehajte uporabljati zdravila Trimbow in ne zmanjšujte odmerka, četudi se počutite bolje ali nimate simptomov.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Trimbow, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Slovenian: Vi in zdravnik se morate odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Trimbow, pri čemer morate pretehtati prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: Caution is also required when Trimbow is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Slovenian: Previdnost je potrebna tudi pri uporabi zdravila Trimbow pri bolnikih s tirotoksikozo, sladkorno boleznijo, feokromocitomom in nezdravljeno hipokaliemijo.
English: Trimbow contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Slovenian: Zdravilo Trimbow vsebuje beklometazondipropionat, formoterol in glikopironij v obliki raztopine, iz katere nastane aerosol z izredno majhnimi delci s srednjim masnim aerodinamičnim premerom (MMAD - mass median aerodynamic diameter) približno 1,1 mikrometra in kodepozicijo treh učinkovin.
English: Cleaning of the Trimbow inhaler
Slovenian: Čiščenje inhalatorja z zdravilom Trimbow
English: The most frequently reported adverse reactions with Trimbow were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Slovenian: Najpogostejši neželeni učinki zdravila Trimbow so bili oralna kandidiaza (pojavila se je pri 0,8 % izpostavljenih oseb), ki je normalno povezana z inhalacijskimi kortikosteroidi; mišični spazmi (0,4 %), ki se lahko pripišejo sestavini dolgodelujočega agonista adrenergičnih receptorjev beta2; suha usta (0,4 %), kar je običajni antiholinergični učinek.
English: You should not use Trimbow during breast-feeding.
Slovenian: Zdravila Trimbow ne uporabljajte med dojenjem.
English: Therefore, as a precautionary measure, it is preferable to avoid the use of Trimbow during pregnancy and during labour.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo in med porodom uporabi zdravila Trimbow bolje izogibati.
English: No specific studies have been performed with Trimbow with regard to the safety in human fertility.
Slovenian: Specifičnih študij varnosti zdravila Trimbow glede plodnosti pri ljudeh niso izvedli.
English: There are no or limited amount of data from the use of Trimbow in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi zdravila Trimbow pri nosečnicah ni oziroma so omejeni.
English: Trimbow is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Slovenian: Zdravilo Trimbow je opremljeno s števcem odmerkov ali kazalnikom odmerkom, ki je na zadnji strani inhalatorja in kaže, koliko sprožitev je še ostalo.
English: In repeat dose inhalation studies with Trimbow in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Slovenian: V inhalacijskih študijah toksičnosti pri ponavljajočih odmerkih z zdravilom Trimbow pri podganah in psih, ki so trajale do 13 tednov, so bile glavne opažene spremembe povezane z učinki na imunski sistem (verjetno zaradi sistemskih učinkov kortikosteroidov beklometazondipropionata in njegovega aktivnega presnosvka beklometazon 17-monopropionata) in na kardiovaskularni sistem (verjetno povezano z beta2 adrenergičnim delovanjem formoterola formoterola in antimuskarinskim delovanjem glikopironija).
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trimbow with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Slovenian: Prav tako se zaradi antiholinergičnega učinka glikopironija dolgotrajnega sočasnega dajanja zdravila Trimbow z drugimi zdravili, ki vsebujejo antiholinergike, ne priporoča (glejte poglavje 4.5).
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Trimbow than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium.
Slovenian: Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (zmanjšanje glede na izhodišče za 4 ali več) po 26 oz. 52 tednih zdravljenja z zdravilom Trimbow v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola in s tiotropijem.
English: If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Trimbow inhaler and use your quick-acting “reliever” inhaler straightaway.
Slovenian: Če se vam takoj po inhaliranju zdravila poslabša kratka sapa ali piskajoče dihanje (dihanje s piskajočim zvokom), nehajte uporabljati zdravilo Trimbow in nemudoma uporabite hitrodelujoči
English: In patients with severe hepatic impairment, Trimbow should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter se lahko zdravilo Trimbow uporablja le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 5.2).
English: In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Trimbow (increase in heart rate, decrease in blood pressure, ECG changes at higher doses), effects probably mainly related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium.
Slovenian: V inhalacijski študiji s telemetriranimi psi je bil kardiovaskularni sistem glavni ciljni sistem za akutne učinke zdravila Trimbow (zvišanje srčnega utripa, zmanjšanje krvnega tlaka, spremembe na EKG pri večjih odmerkih), kar so učinki, ki so najverjetneje v glavnem povezani z beta2 adrenergičnim delovanjem formoterola in antimuskarinskim delovanjem glikopironija.
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Trimbow than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Slovenian: Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (fokalni seštevek 1 ali več) po 26 tednih zdravljenja z zdravilom Trimbow v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola (57,4 % v primerjavi z 51,8 %; p = 0,027).
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trimbow with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Slovenian: Uporaba z nastavkom Farmakokinetični podatki po enkratnem odmerku (glejte poglavje 5.2) so pokazali, da je v primerjavi z redno uporabo brez nastavka uporaba zdravila Trimbow z nastavkom AeroChamber Plus povečala skupno sistemsko izpostavljenost (AUC0-t) glikopironiju.
English: This study also investigated the potential pharmacokinetic interaction between the active components of Trimbow by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Slovenian: Ta študija je preučila tudi morebitne farmakokinetične interakcije med učinkovinami v zdravilu Trimbow na tak način, da je primerjala farmakokinetične podatke, pridobljene po enkratneme odmerku trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija ali po enem odmerku posamičnih sestavin beklometazondipropionata /formoterola ali glikopironija.
English: If you forget to use Trimbow
Slovenian: Če ste pozabili uporabiti zdravilo Trimbow
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trimbow in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: Trimbow za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Trimbow is for inhalation use.
Slovenian: Zdravilo Trimbow se uporablja za inhaliranje.
English: It is preferable to avoid the use of Trimbow during labour due to the inhibitory effects of formoterol on uterine contractions.
Slovenian: Med rojevanjem se je uporabi zdravila Trimbow bolje izogniti zaradi zaviralnih učinkov formoterola na krčenje maternice.
English: There is no relevant use of Trimbow in the paediatric population (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo Trimbow ni namenjeno za uporabo pri pediatrični populaciji (pri otrocih, starih do 18 let) za indikacijo kronične obstruktivne pljučne bolezni (KOPB).
English: For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Trimbow are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Slovenian: Beklometazondipropionat v obliki izredno majhnih delcev ima veliko močnejši učinek kot formulacije, kjer porazdelitev ni v obliki izredno majhnih delcev (100 mikrogramov beklometazondipropionata v obliki izredno majhnih delcev v zdravilu Trimbow ustreza 250 mikrogramom beklometazondipropionata v formulacijah, ki niso v obliki izredno majhnih delcev).
English: What Trimbow looks like and contents of the pack
Slovenian: Izgled zdravila Trimbow in vsebina pakiranja
English: Trimbow should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Slovenian: Zdravilo Trimbow je treba pri bolnikih z aktivno ali mirujočo pljučno tuberkulozo ter glivično in virusno okužbo dihal uporabljati previdno.
English: How to use Trimbow
Slovenian: Kako uporabljati zdravilo Trimbow
English: If you are already using Trimbow
Slovenian: Če že uporabljate zdravilo Trimbow
English: Compared with tiotropium, Trimbow significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Slovenian: V primerjavi s tiotropijem je zdravilo Trimbow značilno izboljšalo IC za 39 ml (p = 0,025) oz. 60 ml (p = 0,001) po 26 oz. 52 tednih zdravljenja.
English: After oral administration (40 to 80 micrograms), 6% to 10% of the dose was recovered in urine as unchanged active substance in healthy subjects; up to 8% of the dose was recovered as the glucuronide.
Slovenian: so pri zdravih prostovoljcih 6 % do 10 % odmerka potrdili v urinu v obliki nespremenjene učinkovine; do 8 % odmerka so potrdili v obliki glukuronida.
English: If you stop using Trimbow
Slovenian: Če ste prenehali uporabljati zdravilo Trimbow
English: Trimbow comes in a pressurised container (coated aluminium), with a metering valve.
Slovenian: Zdravilo Trimbow je na voljo v tlačnem vsebniku (obloženem z aluminijem) z odmernim ventilom.
English: Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Slovenian: Trimbow 87 mikrogramov/5 mikrogramov/9 mikrogramov inhalacijska raztopina pod tlakom
English: • Disulfiram, a medicine used in the treatment of people with alcoholism (drinking problems) or metronidazole, an antibiotic to treat infection in your body can cause side effects (e.g. feeling sick, being sick, stomach pain) due to the small amount of alcohol in Trimbow.
Slovenian: • disulfiram, zdravilom, ki se uporablja za zdravljenje ljudi z alkoholizmom ali metrodinazolom, antibiotikom za zdravljenje okužb v telesu lahko zaradi majhne količine alkohola v zdravilu
English: Trimbow is a pressurised inhalation, solution.
Slovenian: Zdravilo Trimbow je inhalacijska raztopina pod tlakom.
English: Study TRILOGY compared Trimbow with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Slovenian: V študiji TRILOGY so primerjali zdravilo Trimbow s fiksno kombinacijo beklometazondipropionata in formoterola 100/6 mikrogramov, dve inhalaciji dvakrat na dan (1.368 randomiziranih bolnikov).
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Slovenian: V primerjavi zdravila Trimbow in trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija, niso opazili razlik (razlika 3 ml v FEV1 pred odmerkom po 52 tednih zdravljenja).
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trimbow improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Slovenian: V primerjavi s fiksno kombinacijo indakaterola in glikopironija je zdravilo Trimbow izboljšalo povprečni FEV1 pred odmerkom po 52-tedenskem zdravljenju za 22 ml (p = 0,018).
English: Talk to your doctor or pharmacist before using Trimbow:
Slovenian: Pred začetkom uporabe zdravila Trimbow se posvetujte z zdravnikom ali farmacevtom:
English: Compared with tiotropium, Trimbow also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Slovenian: V primerjavi s tiotropijem je zdravilo Trimbow zmanjšalo tudi stopnjo hudih poslabšanj (tj. brez zmernih poslabšanj) za 32 % (razmerje: 0,067 v primerjavi z 0,098 dogodka na bolnika/leto; p = 0,017).
English: Trimbow is used as a maintenance treatment for your COPD.
Slovenian: Zdravilo Trimbow se uporablja za vzdrževalno zdravljenje KOPB.
English: Related to Trimbow
Slovenian: V povezavi z zdravilom Trimbow
English: No differences were observed when comparing Trimbow with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Slovenian: V primerjavi zdravila Trimbow s trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija, niso opazili razlik (razmerje zmernih/hudih poslabšanj: 0,46 v primerjavi z 0,45 dogodka na bolnika/leto).
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Slovenian: V primerjavi zdravila Trimbow in trojne kombinacije, sestavljene iz fiksne kombinacije flutikazona in vilanterola plus tiotropija ni bilo opaznih razlik.
English: Compared with tiotropium, Trimbow improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Slovenian: V primerjavi s tiotropijem je zdravilo Trimbow izboljšalo FEV1 pred odmerkom za 51 ml po 26-tedenskem zdravljenju in za 61 ml po 52-tedenskem zdravljenju.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Trimbow active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Slovenian: (telesna masa manj kot 40 kg in sočasno stopnja glomerularne filtracije pod 27 ml/min/1,73 m²) izpostavljenost učinkovinam v zdravilu Trimbow ostala v razponu približno 2,5-kratnika v primerjavi z izpostavljenostjo običajnega bolnika z mediano vrednostjo sospremenljivk.
English: Study TRINITY compared Trimbow with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Slovenian: 18 mikrogramov praška za inhaliranje, trda kapsula, ena inhalacija enkrat na dan; poleg tega so učinke primerjali s trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola 100/6 mikrogramov, dve inhalaciji dvakrat na dan, plus tiotropij 18 mikrogramov prašek za inhaliranje, trda kapsula, ena inhalacija enkrat na dan (2.691 randomiziranih bolnikov).
English: Use of Trimbow in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2).
Slovenian: ki zahteva dializno zdravljenje, zlasti v povezavi s pomembnim zmanjšanjem telesne mase, je možna le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 4.4 in poglavje 5.2).
English: TRIBUTE was a 52-week activecontrolled study comparing Trimbow with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Slovenian: 52-tedenska študija, nadzorovana z učinkovino, v kateri so primerjali zdravilo Trimbow s fiksno kombinacijo indakaterola/glikopironija 85/43 mikrogramov prašek za inhaliranje, trda kapsula, ena inhalacija enkrat na dan (1.532 randomiziranih bolnikov).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Slovenian: V primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola je zdravilo Trimbow značilno izboljšalo FEV1 2 uri po odmerku za 117 ml po 26-tedenskem zdravljenju in za 103 ml po 52-tedenskem zdravljenju (p < 0,001).
English: Immediate hypersensitivity reactions have been reported after administration of Trimbow.
Slovenian: Preobčutljivost Po jemanju zdravila Trimbow so poročali o takojšnjih preobčutljivostnih reakcijah.
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment.
Slovenian: V primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola je zdravilo Trimbow izboljšalo FEV1 pred odmerkom za 81 ml po 26-tedenskem zdravljenju in za 63 ml po 52-tedenskem zdravljenju.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043).
Slovenian: V primerjavi s fiksno kombinacijo indakaterola in glikopironija je zdravilo Trimbow v 52 tednih zmanjšalo stopnjo zmernih/hudih poslabšanj za 15 % (razmerje: 0,50 v primerjavi z 0,59 dogodka na bolnika/leto; p = 0,043).