natgillin/translations-raw huggingface dataset:
The efficacy of aripiprazole was studied in paediatric subjects with Tourette’s disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Djelotvornost aripiprazola bila je ispitana u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 99, placebo: n = 44) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 8 tjedana u kojem su terapijske skupine primale fiksne doze na temelju tjelesne težine u rasponu od 5 mg na dan do 20 mg na dan, uz početnu dozu od 2 mg.
The efficacy of aripiprazole was studied in paediatric subjects with Tourette’s disorder (aripiprazole: n=99, placebo: n=44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight- based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Djelotvornost aripiprazola bila je ispitana u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 99, placebo: n = 44) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 8 tjedana u kojem su terapijske skupine primale fiksne doze na temelju tjelesne težine u rasponu od 5 mg na dan do 20 mg na dan, uz početnu dozu od 2 mg.
The efficacy of asenapine in the treatment of a DSM-IV manic or mixed episode of bipolar I disorder with or without psychotic features was evaluated in two similarly designed 3-week, randomized, double-blind, flexible-dose, placebo- and active controlled (olanzapine) monotherapy trials involving 488 and 489 patients, respectively.
Djelotvornost asenapina u liječenju maničnih ili miješanih epizoda u bipolarnom poremećaju tipa I (prema DSM-IV) s psihotičnim značajkama ili bez njih ocijenjena je u dva trotjedna randomizirana, dvostruko slijepa ispitivanja s promjenjivom dozom u monoterapiji, koja su bila slično osmišljena te kontrolirana placebom (488 bolesnika), odnosno aktivnim lijekom (olanzapinom) (489 bolesnika).
The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placebo- and active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial.
Djelotvornost bazedoksifena utvrđena je u dva multicentrična, dvostruko slijepa, randomizirana, placebom i aktivnim lijekom kontrolirana ispitivanja faze III: trogodišnjem ispitivanju liječenja osteoporoze i dvogodišnjem ispitivanju prevencije osteoporoze.
The efficacy of Benlysta was evaluated in 2 randomized, double-blind, placebo-controlled studies in 1,684 patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria.
Djelotvornost lijeka Benlysta bila je ocijenjena u dvije randomizirane, dvostruko slijepe, placebom kontrolirane studije u 1684 bolesnika s kliničkom dijagnozom SLE-a prema klasifikacijskim kriterijima American College of Rheumatology.
The efficacy of Bexsero has not been evaluated through clinical trials.
Djelotvornost Bexsera nije procjenjivana u kliničkim ispitivanjima.
The efficacy of canagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Djelotvornost kanagliflozina ovisi o bubrežnoj funkciji, te je smanjena u bolesnika koji imaju umjereno oštećenje bubrega i vjerojatno nije prisutna u bolesnika sa teškim oštećenjem bubrega (vidjeti dio 4.2).
The efficacy of Cerenia in reduction of nausea in cats was demonstrated in studies using a model (xylazine-induced nausea).
Učinkovitost Cerenie za smanjivanje mučnine dokazana je ispitivanjima korištenjem modela (mučnina izazvana ksilazinom).
The efficacy of Cerenia in reduction of nausea was demonstrated in studies using a model (xylazine- induced nausea).
Učinkovitost Cerenie za smanjivanje mučnine dokazana je ispitivanjima korištenjem modela (mučnina izazvana xylazinom).
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Djelotvornost lijeka Cerezyme na neurološke simptome u bolesnika s kroničnom neuropatskom Gaucherovom bolešću nije utvrđena i zato se za te manifestacije ne može preporučiti poseban režim doziranja (vidjeti dio 5.1).
The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial (HPV-015) that included a total of 5777 women aged 26 years and older.
Djelotvornost cjepiva Cervarix procijenjena je u dvostruko slijepom, randomiziranom kliničkom ispitivanju faze III (HPV-015) koje je uključilo ukupno 5777 žena u dobi od 26 godina i više.
The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
Djelotvornost cjepiva Cervarix je procjenjivana u dva kontrolirana, dvostruko slijepa randomizirana klinička ispitivanja faze II i III, u koja je ukupno uključeno 19 778 žena u dobi od 15 do 25 godina.
The efficacy of cetuximab in paediatric patients below the age of 18 years has not been established.
Djelotvornost cetuksimaba kod pedijatrijskih bolesnika mlađih od 18 godina nije utvrđena.
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Djelotvornost klopidogrela zabilježena je neovisno o dozi ASA-a (75 – 325 mg jednom dnevno).
The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastro- intestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal products (see section 4.5).
Djelotvornost kombiniranih oralnih kontraceptiva može biti smanjena u slučaju npr. propuštenih tableta (vidjeti dio 4.2), probavnih poremećaja tijekom uzimanja tableta s djelatnim tvarima (vidjeti dio 4.2) ili istodobnog uzimanja lijekova (vidjeti dio 4.5).
The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastro-intestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal products (see section 4.5).
Djelotvornost kombiniranih oralnih kontraceptiva može biti smanjena u slučaju npr. propuštenih tableta (vidjeti dio 4.2), probavnih poremećaja tijekom uzimanja tableta s djelatnim tvarima (vidjeti dio 4.2) ili istodobnog uzimanja lijekova (vidjeti dio 4.5).
The efficacy of Cotellic was evaluated in Phase Ib Study, NO25395, which was designed to assess the safety, tolerability, pharmacokinetics and efficacy of Cotellic when added to vemurafenib for the treatment of patients with BRAFV600 mutation-positive (as detected by the cobas® 4800 BRAF V600 Mutation Test), unresectable or metastatic melanoma.
Djelotvornost lijeka Cotellic ocjenjivala se u ispitivanju faze Ib NO25395, koje je bilo dizajnirano da ocijeni sigurnost, podnošljivost, farmakokinetiku i djelotvornost lijeka Cotellic kao dodatka vemurafenibu u liječenju bolesnika s neoperabilnim ili metastatskim melanomom pozitivnim na mutaciju BRAF V600 (koja je potvrđena testom cobas® 4800 BRAF V600 Mutation Test).
The efficacy of Cubicin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Djelotvornost Cubicina u bolesnika s infekcijama umjetnih zalistaka ili s lijevostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus nije dokazana.
The efficacy of dabrafenib in the treatment of adult patients with BRAF V600 mutation positive unresectable or metastatic melanoma has been evaluated in 3 studies (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], and BRF113710 [BREAK-2]) including patients with BRAF V600E and/or V600K mutations.
Djelotvornost dabrafeniba u liječenju odraslih bolesnika s inoperabilnim ili metastatskim melanomom pozitivnim na BRAF V600 mutaciju procijenjena je u 3 ispitivanja (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], i BRF113710 [BREAK-2]) uključujući bolesnike s BRAF V600E i/ili V600K mutacijama.
The efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Djelotvornost dapagliflozina ovisi o bubrežnoj funkciji pa je tako njegova djelotvornost smanjena u bolesnika s umjerenim oštećenjem bubrežne funkcije, dok će u bolesnika s teškim oštećenjem bubrega vjerojatno u potpunosti izostati (vidjeti dio 4.2).
The efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Djelotvornost dapagliflozina ovisi o bubrežnoj funkciji, pa je tako njegova djelotvornost smanjena u bolesnika s umjerenim oštećenjem bubrežne funkcije, dok će u bolesnika s teškim oštećenjem bubrega vjerojatno u potpunosti izostati (vidjeti dio 4.2).
The efficacy of dapagliflozin was also assessed separately in a dedicated study of diabetic subjects with moderate renal impairment (252 subjects with mean eGFR 45 ml/min/1.73 m2).
Djelotvornost dapagliflozina također je zasebno ocijenjena u posebnom ispitivanju bolesnika sa šećernom bolešću i umjerenim oštećenjem bubrežne funkcije (252 ispitanika sa srednjom vrijednošću eGFR od 45 ml/min/1,73 m2).
The efficacy of dolutegravir in HIV-infected, therapy naïve subjects is based on the analyses of 96-week data from two randomized, international, double-blind, active-controlled trials, SPRING-2 (ING113086) and SINGLE (ING114467).
Djelotvornost dolutegravira u bolesnika s HIV infekcijom koji prethodno nisu bili liječeni temelji se na analizi podataka prikupljenih tijekom 96 tjedana u dvama randomiziranim, međunarodnim, dvostruko slijepim aktivno kontroliranim ispitivanjima SPRING-2 (ING113086) i SINGLE (ING114467).
The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Djelotvornost dronedarona u smanjivanju rizika hospitalizacije povezane s fibrilacijom atrija dokazana je u bolesnika s trenutnom ili u anamnezi prisutnom FA te dodatnim faktorima rizika u sklopu multicentričnog, međunarodnog, dvostruko slijepog i randomiziranog, placebom kontroliranog ispitivanja ATHENA.
The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double- blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Djelotvornost duloksetina pri preporučenoj dozi od 60 mg jednom dnevno pokazana je u tri od tri randomizirana, dvostruko slijepa, placebom kontrolirana kratkoročna ispitivanja fiksnih doza u odraslih ambulantno liječenih bolesnika s velikim depresivnim poremećajem.
The efficacy of Dynastat was established in studies of dental, gynaecologic (hysterectomy), orthopaedic (knee and hip replacement), and coronary artery bypass graft surgical pain.
Djelotvornost Dynastata ustanovljena je u ispitivanjima kod kirurškog bola nakon stomatoloških, ginekoloških (histerektomija), ortopedskih (zamjena koljena i kuka) operacija i operacija ugradnje arteriokoronarne premosnice.
The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1)
Djelotvornost lijeka Ecalta procijenjena je samo u ograničenog broja bolesnika s neutropenijom (vidjeti dio 5.1).
The efficacy of eculizumab treatment in paediatric PNH patients appears to be consistent with that observed in adult PNH patients enrolled in PNH pivotal Studies (C04-001 and C04-002) (Table 3 and 9).
Djelotvornost terapije ekulizumabom u pedijatrijskih bolesnika s PNH-om čini se sukladna onoj opaženoj u odraslih bolesnika s PNH-om uključenih u ključna ispitivanja PNH-a (C04-001 i C04-002) (tablice 3 i 9).
The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg Enbrel with placebo.
Djelotvornost Enbrela pri ankilozantnom spondilitisu ispitivana je u 3 randomizirana, dvostruko slijepa ispitivanja uspoređujući Enbrel 25 mg primijenjen dva puta tjedno s placebom.
The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg Enbrel with placebo.
Djelotvornost Enbrela pri ankilozantnom spondilitisu ispitivana je u 3 randomizirana, dvostruko slijepa ispitivanja uspoređujući Enbrel 25 mg primijenjen dva puta tjedno s placebom.
The efficacy of Enbrel in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Djelotvornost lijeka Enbrel u bolesnika s aksijalnim spondiloartritisom bez radiografskog dokaza (nr- AxSpa, engl. non-radiographic axial spondyloarthritis) procijenjena je u randomiziranom, 12- tjednom, dvostruko slijepom, placebom kontroliranom ispitivanju.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Djelotvornost Enbrela procijenjena je u dvostruko slijepom, placebom kontroliranom, randomiziranom ispitivanju na 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s umjerenom do teškom plak psorijazom (prema definiciji sPGA bodovanja ≥3, uključujući ≥10% BSA i PASI ≥12).
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Djelotvornost Enbrela procijenjena je u dvostruko slijepom, placebom kontroliranom randomiziranom ispitivanju na 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s umjerenom do teškom plak psorijazom (prema definiciji sPGA bodovanja ≥3, uključujući ≥10% BSA i PASI ≥12).
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Djelotvornost Enbrela procijenjena je u dvostruko slijepom, placebom kontroliranom, randomiziranom ispitivanju na 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s umjerenom do teškom plak psorijazom (prema definiciji sPGA bodovanja ≥3, uključujući ≥10% BSA i PASI ≥12).
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Djelotvornost Enbrela ispitivana je u randomiziranom, dvostruko slijepom placebom kontroliranom ispitivanju.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Djelotvornost Enbrela ispitivana je u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
Djelotvornost Enbrela uspoređena je s metotreksatom u randomiziranom, aktivno kontroliranom ispitivanju s radiografskom ocjenom na slijepo kao primarnom mjerom ishoda, kod 632 odrasla bolesnika s aktivnim reumatoidnim artritisom (<3 godine trajanja) koji nikada nisu bili liječeni metotreksatom.
The efficacy of enzalutamide in patients who have previously received abiraterone acetate has not been studied.
Djelotvornost primjene enzalutamida kod bolesnika koji su prethodno primali abirateron acetat nije ispitana.
The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis and one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, as summarised in Table 9.
Djelotvornost lijeka Epclusa procijenjena je u trima ispitivanjima faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 sa ili bez kompenzirane ciroze te u jednom ispitivanju faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 s dekompenziranom cirozom, što je sažeto prikazano u tablici 9.
The efficacy of Eperzan was evaluated in a 3-year randomised, double-blind, placebo-controlled, multicentre study (n = 296) in patients inadequately controlled on diet and exercise.
Djelotvornost lijeka Eperzan ocijenjena je u 3-godišnjem randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju (n = 296) u bolesnika u kojih glikemija nije bila dovoljno dobro regulirana dijetom i tjelovježbom.
The efficacy of Eperzan was evaluated in a 3-year, randomised (2:1), open-label, insulin glargine-controlled noninferiority study (n = 735).
Djelotvornost lijeka Eperzan ocijenjena je u 3-godišnjem randomiziranom (2:1), otvorenom ispitivanju neinferiornosti kontroliranom inzulinom glarginom (n = 735).
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 999).
Djelotvornost lijeka Eperzan ocijenjena je u 3-godišnjem randomiziranom, dvostruko slijepom, multicentričnom ispitivanju (n = 999).
The efficacy of Eperzan was evaluated in a 32-week, randomised, open-label, liraglutide-controlled noninferiority study (N = 805).
Djelotvornost lijeka Eperzan ocijenjena je u 32-tjednom randomiziranom, otvorenom ispitivanju neinferiornosti kontroliranom liraglutidom (n = 805).
The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215.
Djelotvornost lijeka Eviplera temelji se na analizama podataka iz 96. tjedna prikupljenih u dva randomizirana, dvostruko slijepa, kontrolirana ispitivanja C209 i C215.
The efficacy of Exelon transdermal patches in patients with Alzheimer’s dementia has been demonstrated in a 24-week double-blind, placebo-controlled core study and its open-label extension phase and in a 48-week double-blind comparator study.
Djelotvornost Exelon transdermalnih flastera u bolesnika s Alzheimerovom demencijom dokazana je u 24-tjednom dvostruko slijepom, placebom kontroliranom osnovnom ispitivanju i u njegovom otvorenom produžetku te u 48-tjednom dvostruko slijepom ispitivanju s komparatorom.
The efficacy of FORSTEO in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18- month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Djelotvornost lijeka Forsteo u muškaraca i žena (N=428) dugotrajno liječenih sustavnim glukokortikoidima (ekvivalentno dozi prednizona od 5 mg ili više tijekom najmanje 3 mjeseca) dokazana je u 18-mjesečnoj primarnoj fazi 36-mjesečnog randomiziranog, dvostruko slijepog, usporednim lijekom (alendronat 10 mg/dan) kontroliranog ispitivanja.
The efficacy of Fortacin was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Djelotvornost lijeka Fortacin dokazana je u dvije multicentrične, multinacionalne, randomizirane, dvostruko slijepe, placebom kontrolirane studije, obje naknadno praćene otvorenom fazom.
The efficacy of fosaprepitant was evaluated based on the primary and secondary endpoints listed in Table 2 and was shown to be superior to the control regimen with regard to complete response in the delayed and overall phases.
Djelotvornost fosaprepitanta bila je procijenjena na temelju primarnih i sekundarnih mjera ishoda navedenih u Tablici 2 i pokazalo se da je superiorna djelotvornosti kontrolnog režima u pogledu potpunog odgovora u kasnijoj fazi i ukupno svim fazama.
The efficacy of Gardasil 9 against cervical biopsy related to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 compared to qHPV vaccine was 95.9% (95% CI 92.7 ; 97.9) with 11/6016 versus 262/6018 cases.
Djelotvornost cjepiva Gardasil 9 na smanjenje broja biopsija cerviksa povezanih s tipovima 6, 11, 16, 18, 31, 33, 45, 52 i 58 HPV-a u usporedbi s cjepivom qHPV iznosila je 95,9% (95% CI 92,7; 97,9) uz 11/6016 naspram 262/6018 slučajeva.
The efficacy of Gardasil 9 against CIN 3 related to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 compared to qHPV vaccine was 100% (95% CI 46.3 ; 100.0) with 0/5,952 versus 8/5,947 cases.
Djelotvornost cjepiva Gardasil 9 protiv CIN 3 povezanog s tipovima 6, 11, 16, 18, 31, 33, 45, 52 i 58 HPV-a u usporedbi s cjepivom qHPV iznosila je 100% (95% CI 46,3; 100,0) uz 0/5952 naspram 8/5947 slučajeva.
The efficacy of Gardasil 9 in 16- through 26-year-old women was assessed in an active comparator-controlled, double-blind, randomized clinical study (Protocol 001) that included a total of 14,204 women (Gardasil 9 = 7,099; qHPV vaccine = 7,105).
Djelotvornost cjepiva Gardasil 9 u žena u dobi od 16 do 26 godina bila je ocijenjena u dvostruko slijepom, randomiziranom, kliničkom ispitivanju kontroliranom aktivnim komparatorom (Protokol 001) koje je uključilo ukupno 14 204 žena (Gardasil 9=7099; cjepivo qHPV=7105).
The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Nakon medijana trajanja praćenja od 3,7 godine (na kraju ispitivanja), analizirani su objedinjeni podaci ispitivanja faze III (N = 17 599) u kojima je ispitana djelotvornost cjepiva Gardasil protiv CIN- a (bez obzira na stupanj) i CIN-a 2/3 ili AIS-a uzrokovanih s 10 HPV tipova koji nisu sadržani u cjepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strukturno povezanih s HPV-om 16 odnosno 18.
The efficacy of Gardasil in 16- through 26- year-old women was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Djelotvornost cjepiva Gardasil u žena u dobi od 16 do 26 godina ocijenjena je u 4 placebom kontrolirana, dvostruko slijepa, randomizirana klinička ispitivanja faze II i III obuhvaćajući ukupno 20 541 žena, koje su uključene i cijepljene bez prethodnoga probirnog testiranja na infekciju HPV om.
The efficacy of Gardasil in 16- through 26-year-old men was assessed in 1 placebo-controlled, double- blind, randomized Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Djelotvornost primjene cjepiva Gardasil u muškaraca u dobi od 16 do 26 godina procijenjena je u 1 placebom kontroliranom, dvostruko slijepom, randomiziranom ispitivanju faze III (Protokol 020) koje je obuhvatilo ukupno 4055 muškaraca koji su bili uključeni i cijepljeni bez prethodnog testiranja na prisutnost HPV infekcije.
The efficacy of Gardasil in 24- through 45-year-old women was assessed in 1 placebo-controlled, double-blind, randomized Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Djelotvornost cjepiva Gardasil u žena u dobi od 24 do 45 godina ocijenjena je u 1 placebom kontroliranom, dvostruko slijepom, randomiziranom kliničkom ispitivanju III faze (Protokol 019, FUTURE III) koje je obuhvatilo ukupno 3817 žena, koje su bile uključene i cijepljene bez prethodnog probirnog testiranja na prisutnost infekcije HPV-om.