natgillin/translations-raw huggingface dataset:
In these patients renal impairment may adversely affect other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure.
U tih bolesnika oštećenje bubrežne funkcije može negativno utjecati na druge putove klirensa (hepatički/metabolizam lijeka u crijevima itd.), što može povećati izloženost.
In these patients requiring cautious dosing, oral formulation should be preferred (see section 5.2).
U tih bolesnika koji zahtijevaju pažljivo doziranje, prednost se daje oralnoj formulaciji (vidjeti dio 5.2).
In these patients Revolade should only be used if clinically indicated and patients should then be closely monitored.
Kod tih bolesnika Revolade se smije primjenjivati samo ako je klinički indiciran, a bolesnike se tada mora pomno pratiti.
In these patients, ACR 20/50/70 responses at Week 52 were of 57%, 25%, and 11% respectively.
U tih bolesnika, odgovori ACR 20/50/70 u 52. tjednu bili su 57%, 25% odnosno 11%.
In these patients, blood clots do not form properly, resulting in longer bleeding time and poor wound healing.
U tih bolesnika ne dolazi do normalnog stvaranja krvnih ugrušaka, što dovodi do duljeg vremena krvarenja i slabog cijeljenja rane.
In these patients, Bortezomib Accord is used in combination with melphalan and prednisone; previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
U ovih bolesnika, Bortezomib Accord se koristi u kombinaciji s melfalanom i prednizonom; bolesnika koji nisu prethodno liječeni i koji će primiti kemoterapiju u visokim dozama nakon čega slijedi transplantacija matičnih stanica.
In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone; previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
U tih bolesnika, lijek Bortezomib Hospira koristi se u kombinaciji s melfalanom i prednizonom; bolesnika koji nisu prethodno liječeni i koji trebaju primiti kemoterapiju u visokim dozama i potom biti podvrgnuti transplantaciji hematopoetskih matičnih stanica.
In these patients, Bortezomib Sun is used in combination with melphalan and prednisone; previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
U ovih se bolesnika lijek Bortezomib Sun koristi u kombinaciji s melfalanom i prednizonom; u bolesnika koji prethodno nisu liječeni i koji trebaju primiti kemoterapiju u visokim dozama te potom biti podvrgnuti transplantaciji hematopoetskih matičnih stanica.
In these patients, Cimzia is given in combination with methotrexate.
Takvim bolesnicima lijek Cimzia daje se u kombinaciji s metotreksatom.
In these patients, clinical remission was achieved in 23% of patients at Week 28 and 32% of patients at Week 52.
Kod tih bolesnika klinička remisija postignuta je kod 23% bolesnika u 28. tjednu, te kod 32% bolesnika u 52. tjednu.
In these patients, clinical remission was achieved in 25% of patients at Week 28 and Week 52.
Kod tih bolesnika klinička remisija postignuta je kod 25% bolesnika u 28. tjednu i 52. tjednu.
In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks.
Kod tih bolesnika klinička remisija postignuta je kod 46% bolesnika u 28 tjedana te kod 41% bolesnika u 52 tjedna.
In these patients, enoxaparin sodium should be prescribed for at least 2 days and the treatment should be continued to achieve its objective.
U ovih se bolesnika enoksaparin-natriji treba propisivati tijekom najmanje 2 dana a liječenje nastaviti dok se ne postigne njegov cilj.
In these patients, enoxaparin sodium should be prescribed for at least 2 days and the treatment should be continued to achieve its objective.
U ovih se bolesnika enoksaparinnatriji treba propisivati tijekom najmanje 2 dana a liječenje nastaviti dok se ne postigne njegov cilj.
In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Pokazalo se da lijek Forsteo u tih bolesnika znatno smanjuje vertebralne (spinalne) i nevertebralne prijelome (slomljene kosti), no ne i prijelom kuka;
In these patients, increases in laboratory values of CK to grade 2 and higher severity had a median time to onset of 12.9 weeks (range 2 to 39 weeks) after initiating Odomzo therapy and a median time to resolution (to normalisation or grade 1) of 12 days (95% CI 8 to 14 days).
U tih bolesnika povećanja laboratorijskih vrijednosti CPK do težine stupnja 2 ili višeg imala su medijan vremena do nastupa od 12,9 tjedana (raspon 2 do 39 tjedana) nakon početka terapije Odomzom te medijan vremena do povlačenja (do normalizacije ili stupnja 1) od 12 dana (95% CI 8 do 14 dana).
In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Kod tih se bolesnika preporučuje pratiti koncentracije vitamina A, D i E ili procijeniti status vitamina K mjerenjem koagulacijskih parametara, a vitamine treba nadoknaditi po potrebi.
In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
U tih se bolesnika preporučuje praćenje vrijednosti vitamina A, D i E i procjena statusa vitamina K mjerenjem parametara koagulacije te po potrebi davanje nadomjestaka vitamina.
In these patients, non-renal events were generally comparable between patients with renal impairment and those without renal impairment, except a >10% higher incidence in dehydration (all grades) was noted (see section 4.4).
U tih su bolesnika događaji nevezani uz bubrege u načelu bili usporedivi između bolesnika s oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom, izuzevši > 10% veću incidenciju dehidracije (svih stupnjeva) (vidjeti dio 4.4).
In these patients, opioids may decrease respiratory drive and increase airway resistance.
Kod tih bolesnika opioidi mogu smanjiti nagon za disanjem i povećati otpor dišnih puteva.
In these patients, opioids may decrease respiratory drive and increase airway resistance.
Kod tih bolesnika opioidi mogu smanjiti nagon za disanjem i povećati otpor dišnih putova.
In these patients, ramucirumab should only be used if the potential benefits of treatment are judged to outweigh the potential risk of progressive hepatic failure.
U tih se bolesnika ramucirumab smije primjenjivati samo ako se prosudi da mogući korisni učinci liječenja nadmašuju mogući rizik od progresivnog zatajenja jetre.
In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
U slučaju nepodnošenja MTX-a ili kad trajno liječenje MTX-om nije primjereno, RoActemra se može primijeniti u obliku monoterapije.
In these patients, the dose titration should be performed with caution.
Kod tih bolesnika titraciju doze mora se provesti s oprezom.
In these patients, the maximum toxicity of Grade 1 or 2 was experienced in 125 (56%) patients, Grade 3 in 76 patients (34%), and Grade 4 in 23 (10%) patients.
Od tih bolesnika, maksimalna toksičnost 1. ili 2. stupnja pojavila se u 125 (56%) bolesnika, 3. stupnja u 76 bolesnika (34%) i 4. stupnja u 23 (10%) bolesnika.
In these patients, the mean change in timed function tests from baseline to Week 48 was better in the ataluren 10-, 10-, 20-mg/kg arm than placebo in time to run/walk 10 meters (better by 3.5 seconds), time to climb 4 stairs (better by 6.4 seconds), and time to descend 4 stairs (better by 5.0 seconds).
U ovih bolesnika, srednja promjena u mjerljivim funkcijskim testovima od početne vrijednosti do 48. tjedna bila je bolja u skupini koja je primala ataluren 10-, 10-, 20-mg/kg nego u skupini koja je primala placebo u vremenu trčanja/hodanja na 10 metara (bolje za 3,5 sekundi), vremenu uspinjanja uz 4 stepenice (bolje za 6,4 sekunde) i vremenu silaska niz 4 stepenice (bolje za 5,0 sekundi).
In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1).
U ovih bolesnika, liječenje uobičajenim laksativima treba prekinuti prilikom početka liječenja lijekom Relistor (vidjeti dio 5.1)
In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1).
U ovih bolesnika, liječenje uobičajenim laksativima treba prekinuti prilikom početka liječenja lijekom Relistor (vidjeti dio 5.1).
In these patients, Velcade is used in combination with melphalan and prednisone; previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant.
U ovih bolesnika, Velcade se koristi u kombinaciji s melfalanom i prednisonom; bolesnika koji nisu prethodno liječeni i koji će primiti kemoterapiju u visokim dozama nakon čega slijedi transplantacija hematopoetskih matičnih stanica.
In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments.
U tih bolesnika, čiji su rezultati liječenja uglavnom loši i za koje ne postoji odgovarajuća terapija, lijek Adcetris mogao bi dovesti do izlječenja ili im omogućiti da se podvrgnu terapijama koje bi mogle biti ljekovite.
In these pharmacokinetic trials, the exposure of atazanavir 300 mg with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg.
U tim je farmakokinetičkim ispitivanjima izloženost atazanaviru u dozi od 300 mg u kombinaciji s kobicistatom u dozi od 150 mg bila u skladu s onom primijećenom kada se kao pojačivač koristio ritonavir u dozi od 100 mg.
In these pooled trials, the median exposure for patients in the INTELENCE arm was 52.3 weeks.
U objedinjenim ispitivanjima, srednja izloženost bolesnika u skupini liječenoj INTELENCE-om bila je 52,3 tjedana.
In these reports the MAH is requested to specifically assess cases for whom there is a loss of efficacy (patients reported to have discontinued Ilaris for lack-of-therapeutic response) to determine whether this is due to changes over time in PK/PD or antibody development (where data is available) or in whom a dose adjustment has led to improved therapeutic response (patients with a dose up titration without discontinuation for lack-of- therapeutic response).
U tim izvješćima nositelj odobrenja mora specifično ocijeniti slučajeve kod kojih postoji gubitak djelotvornosti (bolesnici za koje je zabilježeno da su prestali uzimati Ilaris zbog izostanka terapijskog odgovora) kako bi se utvrdilo je li to zbog promjena tijekom vremena u farmakokinetici/farmakodinamici ili zbog razvoja protutijela (gdje ima dostupnih podataka), ili kod kojih je prilagođavanje doze dovelo do poboljšanog terapijskog odgovora (bolesnici s titracijom doze prema gore bez prekida liječenja zbog izostanka terapijskog odgovora).
In these severe cases concomitant treatment may be necessary.
U takvim ozbiljnim slučajevima dodatno liječenje može biti nužno.
In these situations an individual benefit-risk assessment is mandatory and patients should be monitored for occurrence of QT prolongation.
U tim je situacijama obavezna individualna procjena omjera koristi i rizika, a bolesnike se mora pratiti kako bi se uočio produljeni QT interval.
In these situations the treatment should be carefully supervised, and the clinical benefit of Axura reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Axure.
In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Ebixe.
In these situations the treatment should be carefully supervised, and the clinical benefit of Marixino reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja lijeka Marixino.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Accord assessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito procjenjivati kliničku korist od uzimanja lijeka Memantin Accord.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Merz reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Memantine Merz..
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Merz reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Memantine Merza.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Merz reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a Vaš liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Memantine Merza.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Mylan reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Memantine Mylan.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Memantin ratiopharma.
In these situations you should seek immediate medical care in order to receive treatment with injections of hydrocortisone and extra fluid administration.
U takvim situacijama morate bez odlaganja potražiti liječničku pomoć kako biste primili terapiju hidrokortizona u obliku injekcija te dodatnu tekućinu.
In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale.
U tim stanjima povišeni pulmonalni vaskularni otpor uzrokuje desno lijevi šant kroz foramen ovale ili otvoreni ductus arteriosus, što za posljedicu ima hipoksemiju.
In these studies a total of 94 patients with ALL diagnosis with a history of prior clinical allergic reaction to native E. coli L-asparaginase were exposed to Oncaspar.
U tim je ispitivanjima ukupno 94 bolesnika s dijagnozom akutne limfoblastične leukemije (ALL) i anamnezom prethodne kliničke alergijske reakcije na nativnu L-asparaginazu iz E. coli bilo izloženo Oncasparu.
In these studies Darzalex was not compared with any other treatment.
U tim ispitivanjima lijek Darzalex nije uspoređen niti s jednom drugom terapijom.
In these studies the use of thyroglobulin testing on Thyrogen was found to be more sensitive than thyroglobulin testing on TSHT.
U tim je ispitivanjima zapaženo da je osjetljivost tireoglobulinskog testa nakon primjene lijeka Thyrogen veća u odnosu na provedbu tireoglobulinskog testa uz supresijsku terapiju tireoidnim hormonom.
In these studies treatment with BRINAVESS effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
U tim je ispitivanjima primjenom lijeka BRINAVESS učinkovito postignuta konverzija fibrilacije atrija u sinusni ritam, u usporedbi s placebom (vidjeti Tablicu 2).
In these studies, 1313 patients undergoing major surgery were randomized to PCA with intravenous morphine (1 mg morphine bolus, 5 minute lock-out, total of 10 mg/h) delivered by a pump, and 1288 patients were randomized to IONSYS.
U tim ispitivanjima je 1313 bolesnika podvrgnutih velikom kirurškom zahvatu randomizirano u skupinu koja je primala PCA intravenskim morfinom (bolus morfina od 1 mg, 5 minuta pauze, ukupno 10 mg/h) isporučenog pumpom te
In these studies, 155 patients (59 antiretroviral-naive and 96 antiretroviral-experienced) received once daily REYATAZ oral powder and ritonavir, in combination with two NRTIs.
U tim ispitivanjima 155 bolesnika (59 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i 96 onih koji su prethodno bili liječeni antiretrovirusnim lijekovima) primalo je jednom dnevno REYATAZ oralni prašak i ritonavir u kombinaciji s dva NRTI-ja.
In these studies, 2.4% of 466 placebo treated patients and 2.6% of 470 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.
U tim ispitivanjima, 2,4% od 466 bolesnika koji su primali placebo i 2,6% od 470 bolesnika liječenih preporučenom dozom ustekinumaba prijavilo je štetne događaje koji su se pojavili tijekom ili unutar jednog sata od infuzije.
In these studies, 312 alogliptin/pioglitazone-treated patients were ≥ 65 years old.
U tim je ispitivanjima 312 bolesnika liječenih alogliptinom/pioglitazonom bilo u dobi ≥ 65 godina starosti.
In these studies, 696 alogliptin/metformin-treated patients were ≥ 65 years old.
U tim je ispitivanjima 696 bolesnika liječenih alogliptinom/metforminom bilo u dobi od ≥ 65 godina starosti.
In these studies, Avastin, in combination with carboplatin and paclitaxel, was compared with carboplatin and paclitaxel alone.
U tim je ispitivanjima Avastin, u kombinaciji s karboplatinom i paklitakselom, uspoređen s monoterapijama karboplatinom i paklitakselom.
In these studies, myelofibrosis was not observed in animals after a 4-week post- treatment recovery period, indicating reversibility.
U tim ispitivanjima mijelofibroza nije uočena u životinja 4 tjedna nakon završetka liječenja, što upućuje na to da je ta pojava reverzibilna.
In these studies, patients were given up to 4 treatment cycles of Xiapex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24 -52).
U ovim ispitivanjima bolesnici su primili najviše 4 ciklusa liječenja Xiapexom ili placebom (u 0., 6.,12. i 18. tjednu) i zatim su praćeni tijekom razdoblja praćenja bez liječenja (24.-52. tjedan).
In these studies, patients who were treated with TAGRISSO daily doses of 160 mg and 240 mg experienced an increase in the frequency and severity of a number of typical EGFR TKI-induced AEs (primarily diarrhoea and skin rash) compared to the 80 mg dose.
U tim ispitivanjima, u bolesnika liječenih lijekom TAGRISSO u dozama od 160 mg i 240 mg dnevno, došlo je do povećanja učestalosti i težine niza nuspojava tipično induciranih EGFR TKIem (prvenstveno proljeva i kožnog osipa) u usporedbi s dozom od 80 mg.
In these studies, Perjeta was given with trastuzumab and/or chemotherapy.
U ovim ispitivanjima, Perjeta je primijenjen s trastuzumabom i/ili kemoterapijom.
In these studies, Simponi demonstrated clinically meaningful and statistically significant improvement in HAQ DI from baseline versus control at week 24.
U tim ispitivanjima je s lijekom Simponi postignuto klinički vrijedno i statistički značajno poboljšanje rezultata HAQ DI u tjednu u odnosu na početne vrijednosti, u usporedbi s kontrolnom skupinom.
In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the ‘gold standard’, such as angiography (X-rays of blood vessels).
U ovim ispitivanjima SonoVue nije uspoređen niti s jednim drugim lijekom, no rezultati testa provedenog s lijekom SonoVue uspoređeni su sa „zlatnim standardom”, poput angiografije (rendgenskog snimanja krvnih žila).
In these studies, the estimated 1-year survival rates were 59.2% (95% CI: 53.0 - 64.8) and 46.7% (95% CI: 38.1 - 54.9).
U tim ispitivanjima procijenjene stope jednogodišnjeg preživljenja iznosile su 59,2% (95% CI: 53,0°- 64,8°) i 46,7% (95% CI: 38,1-54,9).
In these studies, the median age was 68 years (range 21-100); 51 % were females.
U ovim ispitivanjima medijan dobi bio je 68 godina (raspon 21 – 100); 51% bolesnika bile su žene.
In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI: - 1858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
Točkovna procjena i intervali pouzdanosti u tim ispitivanjima bili su: 100% (95% CI: -1858,0;100), 100% (95% CI: 21,1;100), 45,4% (95% CI: -81,5;86,6), 74,7 (95% CI :-386,2;99,6).
In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively were observed.
U populacijama bolesnika u ta tri ispitivanja zabilježeno je srednja vrijednost dodatnog sniženja sistoličkog i dijastoličkog krvnog tlaka u ležećem položaju od 7/7 mmHg, 9/5 mmHg, odnosno 8/4 mmHg te srednja vrijednost dodatnog sniženje krvnog tlaka u stojećem položaju od 6/6 mmHg, 11/4 mmHg, odnosno 4/5 mmHg.
In these trials, 603 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles).
U tim je ispitivanjima skupina od 603 bolesnika randomizirana na liječenje kapecitabinom (1250 mg/m²/dvaput dnevno tijekom 2 tjedna, nakon čega je slijedio 1 tjedan pauze, u ciklusima od 3 tjedna).
In these trials, patients were initially required to be stable on the lowest effective dose of anti Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Na početku ovih ispitivanja bolesnici su morali biti stabilni na najnižoj učinkovitoj dozi antiparkinsonika (agonisti dopamina) te su na istom antiparkinsoniku i pri istoj dozi morali ostati tijekom cijelog ispitivanja.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti- Parkinsonian medicinal products and dosages throughout the study.
Na početku ovih ispitivanja bolesnici su morali biti stabilni na najnižoj učinkovitoj dozi antiparkinsonika (agonisti dopamina) te su na istom antiparkinsoniku i pri istoj dozi morali ostati tijekom cijelog ispitivanja.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
U navedenim ispitivanjima se zahtijevalo da bolesnici na početku budu stabilni na najnižim učinkovitim dozama lijekova za Parkinsonovu bolest (dopaminski agonisti) te da ostanu na istim antiparkinsonicima i dozama tijekom cijelog trajanja ispitivanja.
In these trials, vildagliptin was administered as monotherapy in drug- naïve patients with type 2 diabetes or in combination in patients not adequately controlled by other antidiabetic medicinal products.
U tim je ispitivanjima vildagliptin primjenjivan kao monoterapija u bolesnika sa šećernom bolešću tipa 2 koji još nisu primali lijekove za šećernu bolest, ili u kombinaciji u bolesnika u kojih nije bila postignuta odgovarajuća kontrola s drugim antidijabeticima.
In these women the benefits of gonadotropin administration need to be weighed against the risks.
U tih žena treba odvagnuti korist i rizike primjene gonadotropina.
In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
U tih žena YENTREVE možda neće ostvariti korist značajniju od one koja se postiže nešto konzervativnijim bihevioralnim intervencijama.
In this 48- week study no unexpected safety findings were observed in either dosing group.
U ovom 48-tjednom ispitivanju nisu opaženi neočekivana otkrića u području sigurnosti.