natgillin/translations-raw huggingface dataset:
The presence of neoplastic changes, other than osteosarcomas, was also reported in the longer term (12 to 15 months) rat toxicity studies (see section 4.8).
Prisutnost drugih neoplastičkih promjena osim osteosarkoma također je bila zabilježena u dugotrajnijim (12 do 15 mjeseci) ispitivanjima toksičnosti na štakorima (vidjeti dio 4.8).
The presence of persistent anti- natalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Prisustvo perzistirajućih anti- natalizumab protutijela povećalo je klirens natalizumaba oko 3 puta, što je u skladu sa smanjenim koncentracijama natalizumaba u serumu primijećenim u bolesnika koji pokazuju trajno prisustvo protutijela (vidjeti dio 4.8).
The presence of renal impairment should not require a change in dosage.
Prisutnost oštećenja funkcije bubrega ne bi trebala zahtijevati promjenu doziranja.
The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Prisutnost Tg autoprotutijela može se očekivati u 18-40% bolesnika s diferenciranim karcinomom štitnjače i može biti razlogom lažno negativnog nalaza mjerenja tireoglobulina u serumu.
The presence of the disease in the flock should be established before metaphylactic treatment.
Potrebno je utvrditi postojanje bolesti u jatu prije početka metafilaktičkog liječenja.
The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.
Prisustvo bolesti u uzgoju treba biti potvrđeno prije provođenja metafilakse.
The presence of the disease in the herd should be confirmed before preventive treatment.
Treba dokazati prisutnost bolesti u stadu, prije preventivnog liječenja.
The presence of the disease in the herd should be established before metaphylaxis.
Prisutnost bolesti u uzgoju treba ustanoviti prije metafilakse .
The presence of the genetic changes affecting ALK (‘ALK-positive’ status) or ROS1 (‘ROS1-positive’ status) has to be confirmed in advance by appropriate methods.
Prisutnost genetske promjene koja utječe na ALK („ALK pozitivan” status) ili na ROS1 („ROS1-pozitivan” status) mora se unaprijed potvrditi odgovarajućim metodama.
The presence of these metabolites in urine together with the high total body clearance and low urinary excretion of unchanged drug in the urine (~4% of the dose) indicate that decitabine is appreciably metabolized in vivo.
Prisutnost tih metabolita u mokraći, zajedno s visokim ukupnim tjelesnim klirensom i malim izlučivanjem nepromijenjenog lijeka u mokraći (~4% doze) ukazuju da se decitabin znatno metabolizira in vivo.
The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual components.
Prikaz sigurnosnog profila temelji se na iskustvu s Ultibro Breezhalerom i pojedinačnim komponentama.
The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual components.
Prikaz sigurnosnog profila temelji se na iskustvu s Ulunar Breezhalerom i pojedinačnim komponentama.
The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual components.
Prikaz sigurnosnog profila temelji se na iskustvu s Xoterna Breezhalerom i pojedinačnim komponentama.
The presented safety information is derived principally from paediatric patients.
Navedene sigurnosne informacije izvedene su načelno od pedijatrijskih bolesnika.
The preservative in NEVANAC, benzalkonium chloride can discolour soft lenses and may cause eye irritation and corneal side effects (eye surface problems).
Konzervans u lijeku NEVANAC, benzalkonijev klorid, može promijeniti boju mekih leća i izazvati iritaciju oka i nuspojave na rožnici (problemi površine oka).
The preservative in NEVANAC, bezalkonium chloride, can discolour soft lenses and may cause eye irritation and corneal side effects (eye surface problems).
Konzervans u lijeku NEVANAC, benzalkonijev klorid, može promijeniti boju mekih leća i izazvati iritaciju oka i nuspojave na rožnici (problemi površine oka).
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a hazard ratio of 0.771 ((95% CI: 0.614 – 0.967), nominal p value p= 0.0244).
Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti plus veća krvarenja) zbirne analize prijavljena je uz omjer hazarda od 0,771 ((95% CI: 0,614- 0,967), nominalna p vrijednost p=0,0244).
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a hazard ratio of 0.67 ((95% CI: 0.47 - 0.95), nominal p value p=0.027) in favour of rivaroxaban.
Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti plus veća krvarenja) prijavljena je uz omjer hazarda od 0,67 ((95% CI: 0,47- 0,95), nominalna p vrijednost p=0,027) u korist rivaroksabana.
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a hazard ratio of 0.67 ((95% CI: 0.47 – 0.95), nominal p value p=0.027) in favour of rivaroxaban.
Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti plus veća krvarenja) prijavljena je uz omjer hazarda od 0,67 ((95% CI: 0,47- 0,95), nominalna p vrijednost p=0,027) u korist rivaroksabana.
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a hazard ratio of 0.849 ((95% CI: 0.633 - 1.139), nominal p value p= 0.275).
Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti plus veća krvarenja) prijavljena je uz omjer hazarda od 0,849 ((95% CI: 0,633- 1,139), nominalna p vrijednost p=0,275).
The pressure regulator should be used in accordance with the manufacturer’s instruction.
Regulator tlaka potrebno je koristiti u skladu s uputama proizvođača.
The pressure regulator should be used in accordance with the manufacturer’s instructions.
Regulator tlaka potrebno je koristiti u skladu s uputama proizvođača.
The PREVAIL study enrolled chemotherapy-naive patients; whereas the AFFIRM study enrolled patients who had received prior docetaxel.
Ispitivanje PREVAIL uključivalo je bolesnike koji ranije nisu primali kemoterapiju; dok je ispitivanje AFFIRM uključivalo bolesnike koji su ranije primali docetaksel.
The prevalence of conjunctival haemorrhage in patients with non-infectious uveitis of the posterior segment appears to be higher compared with BRVO/CRVO and DME.
Prevalencija krvarenja konjunktive kod bolesnika s neinfektivnim uveitisom stražnjeg segmenta izgleda češća nego u bolesnika s BRVO/CRVO i DME.
The prevalence of ectopic pregnancy after ART was reported to be higher than in the general population.
Prevalencija ektopičnih trudnoća nakon postupaka potpomognute oplodnje veća je u usporedbi s općom populacijom.
The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Prevalencija nositelja HLA-B*1502 u populacijama pripadnika kineskog naroda Han i naroda Tai iznosi oko 10%.
the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
prječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom karcinoma, sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom karcinoma.
the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
prječavanje akutne mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom raka, sprječavanje mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom raka.
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Prevencija kliničkih znakova svinjske kolonske spirohetoze (kolitis) nakon dijagnosticiranja bolesti u uzgoju.
The previous day’s patch must be removed before applying a new one every day (see section 4.9).
Flaster od prethodnog dana mora se ukloniti prije primjene novog flastera svakog dana (vidjeti dio 4.9).
The Prezista 800 milligram tablets are available in packs containing one bottle or three bottles per carton.
PREZISTA tablete od 800 miligrama dostupne su u pakiranjima koja sadrže jednu ili tri bočice u kutiji.
The primary active metabolite comprises 23 to 37% of the total exposure.
Od ukupne izloženosti lijeku, na glavni aktivni metabolit otpada 23 do 37%.
The primary adverse effect of oritavancin administration to rats and dogs was a dose related accumulation of eosinophilic granules in tissue macrophages including hepatocytes, renal cortical epithelial cells, adrenal cells and macrophages of the reticulo endothelial system.
Primarni štetni učinak primjene oritavancina u štakora i pasa bila je nakupljanje eozinofilnih zrnaca povezano s dozom u tkivnim makrofagima, uključujući hepatocite, epitelne stanice bubrežne kore, stanice nadbubrežne žlijezde i makrofage retikuloendotelnog sustava.
The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Primarni cilj ispitivanja - dokazati da inzulin glargin nije inferioran u odnosu na NPH u svim slučajevima hipoglikemije - nije postignut, a zabilježen je trend povećanja broja slučajeva hipoglikemije u skupini koja je primala inzulin glargin [omjer inzulin glargin: NPH (95% CI) = 1,18 (0,97-1,44)].
The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Primarni cilj ispitivanja - dokazati da inzulin glargin nije inferioran u odnosu na NPH u svim slučajevima hipoglikemije - nije postignut, a zabilježen je trend povećanja broja slučajeva hipoglikemije u skupini koja je primala inzulin glargin [omjer inzulin glargin: NPH (95% CI) = 1,18 (0,97-1,44)].
The primary analyses of efficacy were performed on the ATP cohort for efficacy and the TVC.
Primarna analiza djelotvornosti napravljena je u ATP kohorti za djelotvornost i u TVC.
The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrollment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Primarne analize djelotvornosti s obzirom na tipove HPV-a sadržane u cjepivu (HPV 6, 11, 16 i 18) provedene su u populaciji kod koje je ispitivanje djelotvornosti provedeno u skladu s planom ispitivanja [engl. per-protocol efficacy (PPE)] (tj. sve 3 doze cjepiva primijenjene su u roku od 1 godine od uključenja, nije bilo velikih odstupanja od plana ispitivanja, sudionice ispitivanja nisu bile izložene relevantnim tipovima HPV-a prije 1. prve doze i do mjesec dana nakon 3. doze (7. mjesec)).
The primary analysis based on independent Review Committee (IRC) assessment demonstrated a statistically significant - 45% reduction in the risk of disease progression (PD) or death, in patients with iNHL receiving G+B followed by Gazyvaro maintenance, compared with patients receiving bendamustine alone.
Primarna analiza utemeljena na ocjenama neovisnog ocjenjivačkog povjerenstva pokazala je statistički značajno smanjenje rizika od progresije bolesti ili smrti za 45% u bolesnika s iNHL-om liječenih kombinacijom G+B, nakon koje je uslijedila terapija održavanja lijekom Gazyvaro, u odnosu na bolesnike koji su primali samo bendamustin.
The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Primarna analiza podataka iz ispitivanja BM 16550 nakon jedne godine i potvrdna analiza nakon dvije godine pokazale su da režim primjene injekcije od 3mg svaka tri mjeseca nije inferioran peroralnoj primjeni od 2,5mg dnevno, u pogledu prosječnog povećanja BMD lumbalne kralježnice, cijelog kuka, vrata bedrene kosti i trohantera (tablica 2).
The primary analysis of investigator-assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Primarna analiza preživljenja bez progresije bolesti prema procjeni ispitivača i na temelju podataka prikupljenih do 28. veljače 2010. pokazuje nestratificirani omjer rizika od 0,79 (95% CI: 0,68-0,91; p-vrijednost dvostranog log-rang testa = 0,0010), uz medijan preživljenja bez progresije bolesti od 16,0 mjeseci u skupini CP te 18,3 mjeseca u skupini CPB7.5+.
The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment naïve and cytokine pre-treated).
Primarna analiza primarne mjere ishoda PFS temeljena je na neovisnoj radiološkoj evaluaciji bolesti za cijelu ispitivanu populaciju (bez ranije terapije i s ranijom terapijom citokinima).
The primary and key secondary endpoints for studies 206207-010 and 011 are presented in Table 2.
Rezultati praćenja primarnih i ključnih sekundarnih ishoda u ispitivanjima 206207-010 i 011 prikazani su u tablici 2.
The primary and key secondary endpoints for the pooled analysis for patients with any prior treatment are presented in Table 4.
Rezultati praćenja primarnih i ključnih sekundarnih ishoda u objedinjenoj analizi bolesnika s bilo kojim prethodnim liječenjem prikazani su u tablici 4.
The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs).
Primarne i sekundarne mjere ishoda bile su pojavnost jednog ili više koštanih događaja (eng. skeletal related event - SRE).
The primary biliary, faecal and urinary metabolites in both the rat and the dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N- demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and also to a lesser extent in the urine.
Primarni bilijarni, fekalni i urinarni metaboliti u štakora i pasa identificirani su kao demetilirani spinozini, konjugati glutationa izvornih spojeva i N-demetiliranih spinosina A i D. Izlučivanje je primarno preko žuči i izmeta i manjim dijelom preko urina.
The primary biotransformation pathway for teriflunomide is hydrolysis with oxidation being a minor pathway.
Primarni biotransformacijski put teriflunomida je hidroliza, a oksidacija je sporedni put.
The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor pathway.
Primarni put biotransformacije teriflunomida je hidroliza, a oksidacija je sporedni put.
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Primarna kardiovaskularna krajnja točka ispitivanja bila je sastavljena od prve pojave smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda ili hospitalizacije zbog nestabilne angine.
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Primarna kardiovaskularna krajnja točka ispitivanja bila je sastavljena od prvog nastupa smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda ili hospitalizacije zbog nestabilne angine.
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Primarna kardiovaskularna krajnja točka ispitivanja bila je sastavljena od prvog nastupa smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda, ili hospitalizacije zbog nestabilne angine.
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Primarna kardiovaskularna krajnja točka ispitivanja bila je sastavljena od prvog nstupa smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda, ili hospitalizacije zbog nestabilne angine.
The primary clinical evidence for the efficacy of cangrelor is derived from CHAMPION PHOENIX, a randomised, double-blind study comparing cangrelor (n=5472) to clopidogrel (n=5470), both given in combination with aspirin and other standard therapy, including unfractionated heparin (78%), bivalirudin (23%), LMWH (14%) or fondaparinux (2.7%).
Primarni klinički dokaz djelotvornosti kangrelora dobiven je u randomiziranom, dvostruko slijepom ispitivanju CHAMPION PHOENIX, u kojem su uspoređivani kangrelor (n= 5472) i klopidogrel (n= 5470), oba davani u kombinaciji s aspirinom i drugom standardnom terapijom, uključujući nefrakcionirani heparin (78%), bivalirudin (23%), heparin male molekulske mase (14%) ili fondaparinuks (2,7%).
The primary composite endpoint was the proportion of patients achieving both an absence of phlebotomy eligibility (HCT control) and a ≥35% reduction in spleen volume from baseline at week 32.
Primarni kompozitni ishod bio je udio bolesnika koji su postigli i odustnost prikladnosti za flebotomiju (kontrola hematokrita) i smanjenje ≥35% u volumenu slezene u 32. tjednu u odnosu na početnu vrijednost.
The primary determination of efficacy was based on demonstration of similar asparagine depletion (magnitude and duration) in the Oncaspar and native E. coli L-asparaginase arms.
Primarno određivanje djelotvornosti temeljeno je na dokazu sličnog pada razine asparagina (opsega i trajanja) u skupinama na Oncasparu i nativnoj L-asparaginazi iz E. coli.
The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 21 and 0.82 times the 50 mg twice daily human clinical exposure based on AUC, respectively.
Primarni učinak dolutegravira bile su gastrointestinalna nepodnošljivost ili iritacija u štakora odnosno majmuna pri dozama koje su izazvale sistemsku izloženost približno 21 odnosno 0,82 puta veću od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a.
The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p<0.01).
Primarna analiza djelotvornosti rezultata ispitivanja nije pokazala statistički značajnu razliku između skupina koje su uzimale 0,10 mg/kg/dan teduglutida i placebo, dok je udio bolesnika koji su uzimali preporučenu dozu od 0,05 mg/kg/dan i postigli smanjenje parenteralne prehrane od barem 20% u tjednima 20 i 24 bio statistički značajno veći u odnosu na placebo (46% naspram 6,3%, p<0,01).
The primary efficacy endpoint evaluated the effect of ataluren on ambulation as assessed by the change in distance (6MWD) walked during a 6MWT.
Primarni ishod djelotvornosti bila je procjena učinka atalurena na pokretljivost putem promjene udaljenosti prijeđene tijekom 6-minutnog testa hoda.
The primary efficacy endpoint for these studies was overall response rate (ORR), defined as the proportion of patients with best response of complete response (CR) or partial response (PR) confirmed by repeat assessments performed not less than 4 weeks after the criteria for response was first met.
Mjera primarnog ishoda djelotvornosti za ova ispitivanja bila je stopa ukupnog odgovora (engl. overall response rate, ORR), definirana kao udio bolesnika kojima je najbolji odgovor bio kompletan odgovor (engl. complete response, CR) ili djelomičan odgovor (engl. partial response, PR) potvrđen ponovljenim pretragama obavljenima najmanje 4 tjedna nakon što su prvi put ispunjeni kriteriji za odgovor.
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV- 1 RNA concentrations < 400 copies/ml over 48 weeks.
Primarna mjera ishoda za djelotvornost u ovom ispitivanju bila je postizanje i održavanje potvrđene koncentracije HIV-1 RNK < 400 kopija/ml tijekom 48 tjedana.
The primary efficacy endpoint in both studies was the mean absolute change from baseline in percent predicted FEV1 through 24 weeks of treatment.
Primarni ishod djelotvornosti u oba ispitivanja bila je prosječna apsolutna promjena postotka predviđenog FEV1 nakon 24 tjedna liječenja u odnosu na početnu vrijednost.
The primary efficacy endpoint in Study MCL-002 was progression-free survival (PFS).
Primarni ishod djelotvornosti u ispitivanju MCL-002 bilo je preživljenje bez napredovanja bolesti (PFS).
The primary efficacy endpoint in this study, OS was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Primarni ishod djelotvornosti u ovom ispitivanju, ukupno preživljenje (OS) bilo je značajno duže (log-rank test, p=0,0058) u skupini liječenoj docetakselom u usporedbi s PF (medijan OS: 70,6 prema 30,1 mjesec), s 30 % smanjenja smrtnosti u usporedbi s PF (omjer hazarda (HR) = 0,70, 95% interval pouzdanosti (CI) = 0,54-0,90) uz ukupni medijan praćenja od 41,9 mjeseci.
The primary efficacy endpoint of the study was OS, which included 381 death events (66% of all randomized patients): 258 (67.2%) deaths in the trabectedin group and 123 (63.7%) deaths in the dacarbazine group (HR 0.927 [95% CI: 0.748, 1.150; p=0.4920]).
Primarni ishod djelotvornosti ispitivanja bilo je OS, što je uključivalo 381 događaj smrti (66% svih randomiziranih bolesnika): 258 (67,2%) smrti u skupini s trabektedinom i 123 (63,7%) smrti u skupini s dakarbazinom (HR 0,927 [95% CI: 0,748; 1,150; p=0,4920]).
The primary efficacy endpoint of the study was TTP, defined as the time from randomization to first documentation of objective tumour progression.
Primarna mjera ishoda djelotvornosti u ispitivanju bio je TTP, definiran kao vrijeme od randomizacije do prve dokumentirane objektivne tumorske progresije.
The primary efficacy endpoint of this study was ORR.
Primarna mjera ishoda djelotvornosti u ovom je ispitivanju bila je stopa objektivnog odgovora (ORR).
The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6-minute walk test or 6MWT) as a measure of endurance, and % predicted forced vital capacity (FVC) as a measure of pulmonary function.
Mjera primarnog ishoda djelotvornosti bio je dvokomponentan kompozitni rezultat koji se temeljio na zbroju rangova promjene od početne vrijednosti na kraju ispitivanja u udaljenosti prehodanoj tokom šest minuta (6-minutni test hodanja ili 6MWT) kao mjera izdržljivosti i % predviđenog forsiranog vitalnog kapaciteta (FVC) kao mjere plućne funkcije.
The primary efficacy endpoint was major molecular response (MMR) at 12 months.
Primarni ishod djelotvornosti bio je veliki molekularni odgovor (MMR – engl. major molecular response) u 12. mjesecu.