FrancophonIA/ELRC3.0 huggingface dataset:
English: Two primary regulators of mTORC1 signalling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2).
Slovenian: Primarna regulatorja signaliziranja z mTORC1 sta dva onkogen supresorja, in sicer tuberin-sklerozna kompleksa 1 & 2 (TSC1 in TSC2).
English: Other medicines and Votubia
Slovenian: Druga zdravila in zdravilo Votubia
English: Patients were randomised in a 2:1 ratio to receive either Votubia or matching placebo.
Slovenian: Bolnike so randomizirali v razmerju 2:1 tako, da so prejemali bodisi zdravilo Votubia ali ustrezen placebo.
English: If you have any questions about Votubia or why it has been prescribed for you, ask your doctor.
Slovenian: Če imate vprašanja o zdravilu Votubia ali vas zanima, zakaj so vam ga predpisali, se obrnite na svojega zdravnika.
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Uporaba everolimusa ni priporočena med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: (see sections 4.2 and 5.2).
Slovenian: (glejte poglavje 5.2).
English: Large increase in everolimus concentration is expected.
Slovenian: Mogoče je pričakovati veliko zvišanje koncentracije everolimusa.
English: No patient developed new lesions, worsening hydrocephalus or increased intracranial pressure, and none required surgical resection or other therapy for SEGA.
Slovenian: Pri nobenem od bolnikov ni prišlo do razvoja novih lezij, poslabšanja hidrocefalusa ali do zvišanja intrakranialnega tlaka in pri nobenem ni bila potrebna kirurška odstranitev ali drugo zdravljenje SEGA.
English: The non-clinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits.
Slovenian: Predklinični varnostni profil everolimusa so ocenjevali pri miših, podganah, prašičkih, opicah in kuncih.
English: Wait for 3 minutes until the dispersible tablets have completely broken apart.
Slovenian: Počakajte 3 minute, da disperzibilne tablete povsem razpadejo.
English: In the absence of clinical data, the possibility of an additive effect on adverse events cannot be excluded when everolimus is given in conjunction with a ketogenic diet.
Slovenian: Ob odsotnosti kliničnih podatkov ne moremo izključiti možnosti aditivnih učinkov na neželene učinke, kadar se everolimus daje sočasno s ketogeno dieto.
English: The p-values for superiority versus placebo were 0.003 (LT) and <0.001 (HT).
Slovenian: P-vrednosti superiornosti v primerjavi s placebom so bile 0,003 (LT) in < 0,001 (HT).
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 4.3 and 0.2 times the estimated clinical exposure.
Slovenian: Uporaba everolimusa v trajanju do 2 leti ni pokazala onkogenega potenciala pri miših in podganah do najvišjih odmerkov, ki so ustrezali 4,3-kratniku oziroma 0,2-kratniku ocenjene klinične izpostavljenosti.
English: Best overall angiomyolipoma response - % Response
Slovenian: Najboljši skupni odziv angiomiolipoma - % Odziv
English: Carefully remove the oral syringe from the patient's mouth.
Slovenian: Previdno potegnite brizgo iz bolnikovih ust.
English: In the oncology safety pooling, 37% of the patients treated with everolimus were ≥65 years of age.
Slovenian: Po združenih podatkih o onkološki varnosti zdravila je bilo 37 % bolnikov, ki so prejemali everolimus, starih ≥65 let.
English: Votubia may elevate cholesterol and/or other blood fats.
Slovenian: Zdravilo Votubia lahko zviša raven holesterola in/ali drugih maščob v krvi.
English: Everolimus can reduce levels of vascular endothelial growth factor (VEGF).
Slovenian: Everolimus lahko zniža koncentracijo rastnega dejavnika za žilni endotelij (VEGF-vascular endothelial growth factor).
English: Monitoring of renal function is recommended (see section 4.4).
Slovenian: Priporočeno je spremljanje delovanja ledvic (glejte poglavje 4.4).
English: 9/l) and no fever.
Slovenian: 9/l) in telesna temperatura ni več zvišana.
English: If you receive Votubia for the treatment of TSC with angiomyolipoma of the kidney, the usual dose is 10 mg, to be taken once daily.
Slovenian: Če zdravilo Votubia prejemate za zdravljenje tuberozne skleroze z angiomiolipomom ledvice, znaša običajen odmerek 10 mg, ki ga je treba vzeti enkrat na dan.
English: In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Slovenian: Pri bolnikih z napredovalim trdim tumorjem je volumen porazdelitve 191 l za navidezni centralni prostor in 517 l za navidezni periferni prostor.
English: Fluconazole
Slovenian: flukonazol
English: Physicians and patients should be aware of the increased risk of infection with Votubia.
Slovenian: Zdravniki in bolniki se morajo zavedati, da zdravilo Votubia povečuje tveganje za okužbe.
English: There was evidence of reversibility.
Slovenian: Opažali so znake reverzibilnosti teh sprememb.
English: Follow all the doctor's instructions carefully.
Slovenian: Skrbno se držite njegovih navodil.
English: The suspension can be prepared either in an oral syringe or in a small glass.
Slovenian: Suspenzijo je mogoče pripraviti bodisi v brizgi za peroralno dajanje ali v majhnem kozarcu.
English: Other symptoms may include altered kidney function test (increase in creatinine).
Slovenian: Drugi simptomi lahko vključujejo spremenjene rezultate pri preverjanjih delovanja ledvic (zvišane ravni kreatinina).
English: St John's Wort (Hypericum perforatum)
Slovenian: šentjanževka (Hypericum Perforatum)
English: In the total population, 57.3% of patients were male and 93.2% were Caucasian.
Slovenian: V celotni populaciji je bilo 57,3 % moških in 93,2 % belcev.
English: If you experience any of these side effects, tell your doctor immediately as this might have lifethreatening consequences.
Slovenian: Če opazite katerega od navedenih neželenih učinkov, takoj obvestite zdravnika, ker imajo ti neželeni učinki lahko življenjsko nevarne posledice.
English: If a higher dose or number of tablets is required, an additional glass must be prepared.
Slovenian: Če je potreben višji odmerek ali večje število tablet, je treba pripraviti še en kozarec.
English: The effect of a ketogenic diet may be mediated through mTOR inhibition.
Slovenian: Ketogena dieta morda učinkuje prek inhibicije mTOR.
English: mTORC1 activation leads to a downstream kinase signalling cascade, including activation of the S6 kinases.
Slovenian: Aktivacija kompleksa mTORC1 sproži kaskado signaliziranja s kinazami, kar vključuje tudi aktivacijo S6 kinaze.
English: • The radioactive metabolites of [3H]everolimus do not significantly cross the blood-brain barrier.
Slovenian: • da radioaktivni metaboliti [3H]everolimusa v večji meri ne prehajajo skozi krvno-možgansko pregrado;
English: The filled syringe should be placed into a container (with the tip pointing up) for 3 minutes, until the Votubia dispersible tablets are in suspension.
Slovenian: Napolnjeno brizgo je treba postaviti v vsebnik (z vrhom obrnjenim navzgor) za 3 minute, dokler disperzibilne tablete Votubia ne razpadejo v suspenzijo.
English: The immune response to vaccination may be affected and, therefore, vaccination may be less effective during treatment with Votubia.
Slovenian: Zdravilo Votubia lahko vpliva na imunski odziv na cepljenje, zato je lahko cepljenje med zdravljenjem z zdravilom Votubia manj učinkovito.
English: Removing air
Slovenian: Odstranjevanje zraka
English: If a dose is missed, the patient should not take an additional dose, but take the usual prescribed next dose.
Slovenian: Če bolnik pozabi vzeti odmerek, naj ne jemlje dodatnega odmerka, temveč naj vzame samo naslednji predpisani odmerek.
English: Refill the glass with the same amount of water (approximately 30 ml), gently stir the remaining content and drink the whole amount to make sure that you get the full dose of Votubia tablets.
Slovenian: V kozarec natočite enako količino vode (približno 30 ml vode), rahlo premešajte s preostankom v kozarcu in spijte celotno vsebino do konca, da zagotovite zaužitje celotnega odmerka zdravila iz tablet Votubia.
English: This may result in the need for insulin and/or oral antidiabetic agent therapy.
Slovenian: Morda boste zato potrebovali insulin in/ali peroralna antidiabetična zdravila.
English: SEGA response rate 95% CI Best overall SEGA response - (%) Response Stable disease Progression Not evaluable according to independent central radiology review SEGA responses were confirmed with a repeat scan.
Slovenian: delež bolnikov z odzivom SEGA 95-odstotni IZ Najboljši skupni odziv SEGA - (%) odziv stabilna bolezen napredovanje ni mogoče oceniti po presoji neodvisnega centralnega pregledovalca radioloških izvidov Odzivi SEGA so bili potrjeni s ponovnim slikanjem.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki pogostnostni skupini so neželeni učinki navedeni po padajoči resnosti.
English: Following the administration of a single dose of radiolabelled everolimus in conjunction with ciclosporin, 80% of the radioactivity was recovered from the faeces, while 5% was excreted in the urine.
Slovenian: Po enkratnem odmerku radioaktivno označenega everolimusa skupaj s ciklosporinom, so 80 % radioaktivnosti prestregli v blatu, 5 % pa se je je izločilo z urinom.
English: These findings were generally observed at systemic exposure levels within the range of therapeutic exposure or above, with the exception of the findings in rats, which occurred below therapeutic exposure due to a high tissue distribution.
Slovenian: To so na splošno opažali pri ravneh sistemske izpostavljenosti v okviru terapevtske izpostavljenosti ali nad njo, z izjemo sprememb pri podganah, ki so se pojavljale pod terapevtsko izpostavljenostjo zaradi velike tkivne porazdelitve.
English: Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Votubia.
Slovenian: Že prisotne okužbe je treba ustrezno zdraviti in jih v celoti odpraviti pred začetkom zdravljenja z zdravilom Votubia.
English: This will look like a cloudy liquid (known as an oral suspension).
Slovenian: Zdravilo bo izgledalo kot motna tekočina (kar imenujemo peroralna suspenzija).
English: In patients with SEGA, everolimus Cmin was approximately dose-proportional within the dose range from 1.35 mg/m to 14.4 mg/m
Slovenian: Pri bolnikih s SEGA je bila Cmin everolimusa približno sorazmerna z višino odmerka v okviru odmerjanja od 1,35 mg/m do 14,4 mg/m
English: Votubia may increase the risk of problems with wound healing.
Slovenian: Zdravilo Votubia lahko poveča tveganje za težave pri celjenju rane.
English: If a diagnosis of invasive systemic fungal infection is made, Votubia treatment should be promptly and permanently discontinued and the patient treated with appropriate antifungal therapy.
Slovenian: Če se pri bolniku ugotovi invazivno sistemsko glivično okužbo, je treba zdravljenje z zdravilom Votubia takoj in dokončno ukiniti, bolnika pa zdraviti z ustreznimi protiglivičnimi zdravili.
English: The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5,000 ng/ml, is 17% to 73%.
Slovenian: Razmerje med koncentracijo everolimusa v krvi in v plazmi, ki je v okviru koncentracij od 5 do 5.000 ng/ml odvisno od koncentracije, je od 17 % do 73 %.
English: PJP/PCP may be associated with concomitant use of corticosteroids or other immunosuppressive agents.
Slovenian: PJP/PCP je lahko povezana s sočasno uporabo kortikosteroidov ali drugih zdravil z imunosupresivnim delovanjem.
English: Baseline seizure frequency and TN-Cmin were both significant factors (α=0.05) in predicting the absolute seizure frequency in the linear regression model.
Slovenian: Tako izhodiščna pogostnost napadov kot TN-Cmin sta statistično pomembna (α=0,05) napovedna dejavnika absolutne pogostnosti napadov v linearnem regresijskem modelu.
English: Not all pack sizes or strengths may be marketed in your country.
Slovenian: V vaši državi morda niso na voljo vse velikosti pakiranj in jakosti zdravila.
English: Based on analysis of population pharmacokinetics, oral clearance (CL/F) is on average 20% higher in black transplant patients.
Slovenian: Na podlagi analize populacijske farmakokinetike je peroralni očistek (CL/F) pri bolnikih črne rase po presaditvi povprečno za 20 % večji.
English: The entire contents of the glass should be administered.
Slovenian: Zaužiti je treba celotno vsebino kozarca.
English: Everolimus binds to the intracellular protein FKBP-12, forming a complex that inhibits mTOR complex-1 (mTORC1) activity.
Slovenian: Everolimus se veže na znotrajcelični protein FKBP-12, s katerim tvori kompleks, ki zavira delovanje mTOR kompleksa-1 (mTORC1).
English: Approximately 5 ml of water and 4 ml of air should be drawn into the syringe.
Slovenian: V brizgo je treba potegniti približno 5 ml vode in 4 ml zraka.
English: Votubia tablets are to be swallowed whole with a glass of water.
Slovenian: Tablete Votubia je treba pogoltniti cele, s kozarcem vode.
English: In the pivotal phase III study in patients with TSC and refractory seizures, 299 of the 366 patients studied were below the age of 18 years.
Slovenian: V osrednji študiji faze III z bolniki s tuberozno sklerozo in neodzivno epilepsijo je bilo 299 izmed 366 proučevanih bolnikov mlajših od 18 let.
English: Push the plunger up slowly to remove most of the air (it is okay for a small amount of air to remain around the tip).
Slovenian: Počasi pritiskajte bat, s čimer boste odstranili večino zraka (nič ni narobe, če pod vrhom brizge ostane nekaj zraka).
English: In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Slovenian: V kliničnih študijah je bil everolimus pogosto povezan z resnimi primeri reaktivacije virusa hepatitisa B, tudi s takimi s smrtnim izidom.
English: A diagnosis of non-infectious pneumonitis should be considered in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough or dyspnoea, and in whom infectious, neoplastic and other non-medicinal causes have been excluded by means of appropriate investigations.
Slovenian: Na diagnozo neinfekcijske pljučnice je treba pomisliti pri bolnikih z nespecifičnimi respiratornimi znaki in simptomi, kot so hipoksija, plevralni izliv, kašelj ali dispneja, in pri katerih so bili z ustreznimi preiskavami izključeni infekcijski, neoplastični in drugi vzroki, ki niso zdravstvene narave.
English: No change >-25 to <25
Slovenian: stopnjevanje brez spremembe >-25 do <25
English: The parent substance was not detected in urine or faeces.
Slovenian: Matične spojine v urinu ali blatu niso našli.
English: After the core treatment phase, patients could be enrolled into an extension phase where SEGA volume was assessed every 6 months.
Slovenian: Po zaključku glavnega obdobja zdravljenja so bolnike lahko vključili v podaljšanje študije, kjer so volumen subependimskega gigantoceličnega astrocitoma ocenjevali vsakih 6 mesecev.
English: You must mix the dispersible tablets with water to create a cloudy liquid (known as an oral suspension).
Slovenian: Disperzibilne tablete morate zmešati z vodo, da nastane motna tekočina (imenujemo jo peroralna suspenzija).
English: Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Slovenian: Zaradi razlik med posamezniki priporočeni odmerki morda ne bodo najbolj ustrezni pri vseh, zato je priporočeno skrbno spremljanje bolnikov glede neželenih učinkov.
English: Steady-state was achieved within 2 weeks.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo v 2 tednih.
English: Includes pneumocystis jirovecii (carinii) pneumonia (PJP, PCP)
Slovenian: Vključuje pljučnico, povzročeno s Pneumocystis jiroveci (carinii) (PJP, PCP)
English: Take Votubia tablets once a day.
Slovenian: Tablete Votubia jemljite enkrat na dan.
English: Renal function of patients should be monitored particularly where patients have additional risk factors that may further impair renal function.
Slovenian: Pri bolnikih je treba spremljati ledvično funkcijo, še zlasti kadar so prisotni tudi drugi dejavniki tveganja, ki lahko dodatno poslabšajo delovanje ledvic.
English: Votubia is available in two pharmaceutical forms: tablets and dispersible tablets.
Slovenian: Zdravilo Votubia je na voljo v dveh farmacevtskih oblikah: kot tablete in kot disperzibilne tablete.
English: Push the plunger in until it touches the dispersible tablets.
Slovenian: Potisnite ga v brizgo tako daleč, da se dotakne disperzibilnih tablet.
English: Care should be taken to ensure the entire dose is ingested.
Slovenian: Potrebno je paziti, da bolnik zagotovo zaužije celoten odmerek.
English: Toxicity study with juvenile monkeys did not show any relevant toxicity.
Slovenian: Rezultati študije toksičnosti na mladih opicah ne kažejo posebnega toksičnega delovanja.
English: If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Votubia.
Slovenian: Če jemljete katero od njih, vam bo zdravnik morda zdravilo zamenjal za drugo ali pa vam bo spremenil odmerek zdravila Votubia.
English: Put the required number of tablets into a glass of water (approximately 30 ml).
Slovenian: Predpisano število tablet stresite v kozarec vode (v približno 30 ml vode).
English: Fill a small glass with water (drinkable tap water or non-sparkling bottled water).
Slovenian: V majhen kozarec nalijte vodo (pitno vodo iz vodovodne pipe ali negazirano ustekleničeno vodo).
English: Non-infectious pneumonitis
Slovenian: Neinfekcijska pljučnica
English: The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m 2.
Slovenian: Priporočeni začetni odmerek zdravila Votubia za zdravljenje bolnikov s SEGA je 4,5 mg/m2.
English: In tuberous sclerosis complex syndrome, inactivating mutations in the TSC1 or the TSC2 gene lead to hamartoma formation throughout the body.
Slovenian: Pri sindromu tuberozne skleroze povzročajo mutacije, ki inaktivirajo gen TSC1 ali gen TSC2, tvorbo hamartomov po celem telesu.
English: Antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin)
Slovenian: antiepileptiki (na primer karbamazepin, fenobarbital, fenitoin)
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Slovenian: Pri neželenih učinkih 1. stopnje prilagajanje odmerka običajno ni potrebno.
English: Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Votubia therapy without dose adjustments.
Slovenian: Bolniki, pri katerih pride do radioloških sprememb, ki bi lahko bile neinfekcijska pljučnica, vendar imajo le malo simptomov ali jih sploh nimajo, lahko nadaljujejo z jemanjem zdravila Votubia brez spremembe odmerka.
English: More frequent monitoring is recommended when Votubia is co-administered with other medicinal products that may induce hyperglycaemia.
Slovenian: Bolj pogosto spremljanje je priporočeno v primeru sočasne uporabe zdravila Votubia z drugimi zdravili, ki lahko sprožijo hiperglikemijo.
English: angiotensin-converting enzyme (ACE) inhibitors (such as ramipril) used to treat high blood pressure or other cardiovascular problems.
Slovenian: zaviralci angiotenzinske konvertaze (na primer ramipril), ki jih uporabljamo za zdravljenje visokega krvnega tlaka ali drugih srčnožilnih obolenj.
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and TSC settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Slovenian: Celotni varnostni profil v tej študiji se je ujemal z varnostnim profilom everolimusa v okviru zdravljenja onkoloških bolezni in TSC, razen nekoliko povečane pogostnosti oralne kandidoze, o kateri so poročali pri 2,2 % (n=2/92) bolnic.
English: Adverse reactions are listed according to MedDRA system organ class.
Slovenian: Neželeni učinki so našteti v skladu s skupinami organskih sistemov po klasifikaciji MedDRA.
English: In the final analysis, reduction in angiomyolipoma volume improved with longer term treatment with Votubia.
Slovenian: V zaključni analizi se je obseg zmanjševanja angiomiolipoma povečeval z daljšim trajanjem zdravljenja z zdravilom Votubia.
English: If you are taking other medicines at the same time as Votubia, your doctor may need to change the dose of Votubia or the other medicines.
Slovenian: Če jemljete druga zdravila sočasno z zdravilom Votubia, vam bo moral zdravnik morda spremeniti odmerke zdravila Votubia ali drugih zdravil.
English: In this case, a dose of 2.5 mg daily must not be exceeded (see sections 4.4
Slovenian: V takem primeru se ne sme prekoračiti odmerka 2,5 mg na dan (glejte poglavji 4.4 in 5.2).
English: If you forget to take Votubia
Slovenian: Če ste pozabili vzeti zdravilo Votubia
English: If you had allergic reactions before, please ask your doctor for advice.
Slovenian: Če ste alergijsko reakcijo že imeli kdaj prej, se posvetujte z zdravnikom.
English: In juvenile rat toxicity studies, systemic toxicity included decreased body weight gain, food consumption, and delayed attainment of some developmental landmarks, with full or partial recovery after cessation of dosing.
Slovenian: V študiji toksičnosti na mladih podganah je sistemsko toksično delovanje obsegalo zmanjšano pridobivanje telesne mase in manjše uživanje hrane ter zakasnelo doseganje nekaterih razvojnih mejnikov, pri čemer je po prenehanju odmerjanja prišlo do delnega ali popolnega okrevanja.
English: • A rapid uptake of everolimus in the brain followed by a slow efflux.
Slovenian: • na hiter privzem everolimusa v možgane, ki mu sledi počasno odstranjevanje;
English: A higher or lower dose may be recommended by your doctor based on your individual treatment needs, for example if you have problems with your liver or if you are taking certain other medicines in addition to Votubia.
Slovenian: Glede na to, kakšno zdravljenje je pri vas potrebno, lahko zdravnik priporoči višji ali nižji odmerek, na primer, če imate težave z jetri, ali če poleg zdravila Votubia jemljete še določena druga zdravila.
English: Management of stomatitis may therefore include prophylactic (in adults) and/or therapeutic use of topical treatments, such as an alcohol-free corticosteroid oral solution as a mouthwash.
Slovenian: Obvladovanje stomatitisa lahko zato vključuje profilaktično (pri odraslih) in terapevtsko uporabo zdravil za lokalno uporabo, kot je kortikosteroidna oralna raztopina brez alkohola v obliki raztopine za izpiranje ust.
English: Refill the glass with the same amount of water (about 25 ml).
Slovenian: V kozarec ponovno nalijte enako količino vode (približno 25 ml).
English: <6 years n=33
Slovenian: <6 let n=33
English: Please read the detailed instructions at the end of this leaflet to find out how to do this.
Slovenian: Da boste vedeli, kako to storiti, si preberite podrobna navodila na koncu tega navodila za uporabo.
English: Genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of clastogenic or mutagenic activity.
Slovenian: Študije genotoksičnosti, ki so zajemale za genotoksičnost pomembne cilje opazovanja, niso pokazale znakov klastogenosti ali mutagenosti.
English: With the possible exception of the rat-specific lens finding (where young animals appeared to be more susceptible), it appears that there is no significant difference in the sensitivity of juvenile animals to the adverse reactions of everolimus as compared to adult animals.
Slovenian: Z morebitno izjemo za podgane specifično ugotovitev glede leč (kaže, da so mlade živali bolj dovzetne kot starejše), ni videti, da bi bile mlade živali bolj občutljive za neželene učinke everolimusa kot odrasle.
English: Results showed that Votubia was superior to placebo for the primary endpoint of best overall SEGA response (p<0.0001).
Slovenian: Rezultati so pokazali, da je bilo zdravilo Votubia boljše od placeba glede primarnega cilja opazovanja: najboljšega skupnega odziva SEGA (p<0,0001).