FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: may affect more than 1 in 10 people o Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache, o Nausea
Croatian: - Vrlo često: mogu se javiti u više od 1 na 10 osoba o upala nosa i grla, neuobičajeni snovi, poteškoće sa spavanjem, glavobolja o mučnina
English: Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Croatian: Prividni volumen distribucije u stanju dinamičke ravnoteže iznosio je prosječno 415 litara (% CV = 50).
English: A meta-analysis of 5 randomised, double-blind, placebo controlled trials, including 1907 patients (1130 varenicline, 777 placebo), was conducted to assess suicidal ideation and behaviour as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Croatian: Metaanaliza 5 randomiziranih, dvostruko slijepih, placebom kontroliranih ispitivanja, koja uključuju 1907 bolesnika (1130 na vareniklinu, 777 na placebu) provedeno je radi procjene suicidalnih ideacija i ponašanja prema Columbia-ljestvici ocjenjivanja ozbiljnosti suicidalnosti (engl.
English: The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Croatian: U trećem je ispitivanju procijenjena korist dodatnih 12 tjedana liječenja lijekom CHAMPIX u svrhu održavanja apstinencije.
English: Steady-state systemic exposure in adolescent patients of bodyweight > 55 kg, as assessed by AUC (0-24), was comparable to that noted for the same doses in the adult population.
Croatian: Sustavna izloženost u stanju dinamičke ravnoteže u adolescenata tjelesne težine > 55 kg, procijenjena na temelju AUC(0-24), bila je usporediva s izloženošću u odraslih ispitanika kod primjene iste doze.
English: CHAMPIX may be linked with dizziness, sleepiness and transient loss of consciousness.
Croatian: CHAMPIX može biti povezan s omaglicom, pospanošću i prolaznim gubitkom svijesti.
English: Serious side effects of either an uncommon or rare frequency have occurred in people attempting to quit smoking with CHAMPIX: seizure, stroke, heart attack, suicidal thoughts, loss of contact with reality and unable to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggression and abnormal behaviour).
Croatian: Ozbiljne nuspojave manje česte ili rijetke učestalosti pojavile su se u osoba koje su pokušavale prestati pušiti s lijekom CHAMPIX: napadaj, moždani udar, srčani udar, suicidalne misli, gubitak doticaja sa stvarnošću i nemogućnost jasnog razmišljanja ili rasuđivanja (psihoza), promjene u razmišljanju ili ponašanju (poput agresije i neuobičajenog ponašanja).
English: Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately.
Croatian: Bolesnici u kojih se jave navedeni simptomi moraju prekinuti liječenje vareniklinom i odmah se obratiti zdravstvenom radniku.
English: Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
Croatian: Stupanj vezanja vareniklina za proteine u plazmi je nizak (≤ 20%), a ne ovisi ni o dobi ni o funkciji bubrega.
English: No dosage adjustment is necessary for elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Croatian: U mladunaca štakorica koje su dobivale vareniklin tijekom graviditeta primijećena je smanjena plodnost i pojačana reakcija straha na zvučne podražaje (vidjeti dio 4.6).
English: Psychiatric Cohort N=4074
Croatian: Psihijatrijska kohorta N=4074
English: Four observational studies, each including 10,000 to 30,000 users of varenicline in the adjusted analyses, compared the risk of serious neuropsychiatric events, including neuropsychiatric hospitalizations and fatal and non-fatal self-harm, in patients treated with varenicline versus patients prescribed NRT or bupropion.
Croatian: Četiri opservacijska ispitivanja, od kojih svako uključuje 10 000 do 30 000 korisnika vareniklina u prilagođenim analizama, uspoređivala su rizik od ozbiljnih neuropsihijatrijskih događaja, uključujući neuropsihijatrijske hospitalizacije te samoozljeđivanja sa smrtnim ishodom ili bez njega, u bolesnika liječenih vareniklinom u usporedbi s bolesnicima kojima je propisana nikotinska zamjenska terapija ili bupropion.
English: Gradual approach to quitting smoking
Croatian: Postepeni pristup prestanku pušenja
English: Tell your doctor if you have experienced seizures or have epilepsy before your start CHAMPIX treatment.
Croatian: Obavijestite svog liječnika ako ste imali napadaje ili epilepsiju prije liječenja lijekom CHAMPIX.
English: 0.5 mg once daily
Croatian: 0,5 mg jedanput na dan
English: The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
Croatian: Primarni ishod sigurnosti bio je kombinacija neuropsihijatrijskih štetnih događaja koji su prijavljeni nakon stavljanja lijeka u promet.
English: In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
Croatian: U bolesnika s teškim oštećenjem bubrega treba izbjegavati istodobnu primjenu cimetidina i vareniklina.
English: No dosage adjustment of CHAMPIX or co-administered medicinal products listed below is recommended.
Croatian: Ne preporučuje se prilagođavati dozu lijeka CHAMPIX ni istodobno primijenjenih lijekova navedenih u nastavku.
English: Risk Ratio
Croatian: Omjer rizika
English: The treatment discontinuation rate due to adverse reactions was 11.4% for varenicline compared with 9.7% for placebo.
Croatian: Stopa prekida liječenja zbog nuspojava bila je 11,4% kod primjene vareniklina, dok je za placebo iznosila 9,7%.
English: Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
Croatian: Osim toga, u ljudskim hepatocitima in vitro vareniklin nije inducirao aktivnost enzima 1A2 i 3A4 citokroma P450.
English: The primary safety endpoint was a composite of the following neuropsychiatric (NPS) adverse events: severe events of anxiety, depression, feeling abnormal, or hostility, and/or moderate or severe events of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour or completed suicide.
Croatian: Primarni ishod bio je kombinacija sljedećih neuropsihijatrijskih (engl. neuropsychiatric, NPS) štetnih događaja: teški događaji tjeskobe, depresije, nenormalnih osjećanja ili neprijateljstva i/ili umjereni ili teški događaji agitacije, agresije, deluzija, halucinacija, homicidalnih ideacija, manije, panike, paranoje, psihoze, suicidalnih ideacija, suicidalnog ponašanja ili ostvarenog samoubojstva.
English: Giving up smoking with or without treatment can cause various symptoms.
Croatian: Prestanak pušenja, uz liječenje ili bez njega, može izazvati različite simptome.
English: CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Croatian: CHAMPIX može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: In rodents, varenicline is transferred through the placenta and excreted in milk.
Croatian: U glodavaca vareniklin prolazi kroz placentu i izlučuje se u mlijeku.
English: Study in subjects re-treated with CHAMPIX
Croatian: Ispitivanje s ispitanicima ponovno liječenim lijekom CHAMPIX:
English: Smoking cessation with or without treatment is associated with various symptoms.
Croatian: Prestanak pušenja, uz liječenje ili bez njega, povezuje se s različitim simptomima.
English: Psychiatric scales showed no differences between the varenicline and placebo groups and no overall worsening of depression, or other psychiatric symptoms, during the study in either treatment group.
Croatian: Psihijatrijske ljestvice nisu pokazale razliku između skupine koja je uzimala vareniklin i one koja je uzimala placebo, kao ni opće pogoršanje depresije ili drugih psihijatrijskih poremećaja tijekom ispitivanja u obje skupine.
English: Through end of study MACE, n (%)
Croatian: Do kraja ispitivanja MACE, n (%)
English: If you are not willing or able to set a target quit date within 2 weeks, you may choose your own target quit date within 5 weeks after starting treatment.
Croatian: Ako ne želite ili ne možete odrediti ciljni datum prestanka pušenja unutar 2 tjedna, možete odabrati ciljni datum prestanka pušenja unutar 5 tjedana nakon početka liječenja.
English: Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/min and  80 ml/min).
Croatian: Farmakokinetika vareniklina ostala je neizmijenjena u ispitanika s blagim oštećenjem bubrega (procijenjeni klirens kreatinina > 50 ml/min i ≤ 80 ml/min).
English: Contains Blue Box
Croatian: Sadrži plavi okvir
English: In a smoking cessation clinical trial, neuropsychiatric adverse events were reported more frequently in patients with a history of psychiatric disorders compared to those without a history of psychiatric disorders, regardless of treatment (see section 5.1).
Croatian: U kliničkim ispitivanjima odvikavanja od pušenja, neuropsihijatrijski štetni događaji zabilježeni su češće u bolesnika s psihijatrijskim poremećajima u anamnezi u usporedbi s onima bez psihijatrijskih poremećaja u anamnezi, neovisno o liječenju (vidjeti dio 5.1).
English: CHAMPIX smoking cessation studies have provided data in patients with a history of psychiatric disorders (see section 5.1).
Croatian: Ispitivanja lijeka CHAMPIX kod odvikavanja od pušenja osigurala su podatke u bolesnika s psihijatrijskim poremećajima u anamnezi (vidjeti dio 5.1).
English: Two identical double-blind clinical trials prospectively compared the efficacy of CHAMPIX (1 mg twice daily), sustained release bupropion (150 mg twice daily) and placebo in smoking cessation.
Croatian: Dva jednaka dvostruko slijepa klinička ispitivanja prospektivno su uspoređivala djelotvornost lijeka CHAMPIX (1 mg dvaput na dan), bupropiona u obliku s produljenim otpuštanjem (150 mg dvaput na dan) i placeba u odvikavanju od pušenja.
English: Number of Patients and Risk Ratio for Suicidal Ideation and/or Behaviour Reported on C-SSRS from a Meta-Analysis of 5 Clinical Trials Comparing Varenicline to Placebo: Varenicline (N=1130)
Croatian: Broj bolesnika i omjer rizika za suicidalne ideacije i/ili ponašanje prijavljen na C-SSRS ljestvici iz metaanalize 5 kliničkih ispitivanja u kojima se vareniklin uspoređuje s placebom: Vareniklin (N=1130)
English: After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
Croatian: Nakon 40 tjedana bez terapije ključna sekundarna mjera ishoda u oba je ispitivanja bila stopa kontinuirane apstinencije (engl. continued abstinence, CA) u 52. tjednu.
English: Varenicline binds with high affinity and selectivity at the α4β2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist - a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine.
Croatian: Vareniklin se visokim afinitetom i selektivnošću veže za α4β2 neuronske nikotinske acetilkolinske receptore, gdje djeluje kao djelomični agonist - tvar koja djeluje i kao agonist, s manjom intrinzičnom djelotvornošću od nikotina, ali i kao antagonist u prisutnosti nikotina.
English: Minor circulating metabolites include varenicline N-carbamoylglucuronide and N-glucosylvarenicline.
Croatian: Sporedni metaboliti u cirkulaciji uključuju vareniklin N-karbamoilglukuronid i N-glukozilvareniklin.
English: In both cohorts, subjects treated with varenicline demonstrated statistical superiority of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo (please see table below).
Croatian: U obje kohorte, ispitanici liječeni vareniklinom pokazali su statističku superiornost apstinencije potvrđene mjerenjem CO-a tijekom 9. do 12.-tog tjedna i 9. do 24. tjedna u usporedbi s ispitanicima liječenim bupropionom, nikotinskim flasterom i placebom (vidjeti tablicu u nastavku).
English: Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
Croatian: Budući da nema dovoljno kliničkog iskustva s primjenom lijeka CHAMPIX u bolesnika u krajnjoj fazi bubrežne bolesti, toj se populaciji ne preporučuje liječenje ovim lijekom (vidjeti dio 5.2).
English: There were no completed suicides reported in the psychiatric cohort.
Croatian: U psihijatrijskoj kohorti nisu prijavljena ostvarena samoubojstva.
English: The meta-analysis showed that exposure to CHAMPIX resulted in a hazard ratio for MACE of 2.83 (95% confidence interval from 0.76 to 10.55, p=0.12) for patients during treatment and 1.95 (95% confidence interval from 0.79 to 4.82, p=0.15) for patients up to 30 days after treatment.
Croatian: Metaanaliza je pokazala da je izloženost lijeku CHAMPIX u bolesnika dovela do omjera rizika za MACE događaje od 2,83 (95% intervala pouzdanosti od 0,76 do 10,55, p=0,12) tijekom liječenja i 1,95 (95% intervala pouzdanosti od 0,79 do 4,82, p=0,15) do 30 dana nakon liječenja.
English: Psychiatric Cohort N=4074 Varenicline Bupropion
Croatian: Psihijatrijska kohorta N=4074 Vareniklin Bupropion
English: The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.
Croatian: Ispitivanja in vitro pokazuju da vareniklin ne inhibira enzime citokroma P450 (IC50 > 6400 ng/ml) Inhibicija je ispitana za sljedeće enzime P450: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4/5.
English: Tablets' core
Croatian: Jezgra tableta
English: After the initial 12-week reduction phase, subjects continued treatment for another 12 weeks.
Croatian: Nakon početne 12-tjedne faze smanjivanja, ispitanici su nastavili liječenje još 12 tjedana.
English: From day 1 to day 3, you should take one white CHAMPIX 0.5 mg film-coated tablet once a day.
Croatian: Od 1. do 3. dana morate uzeti jednu bijelu CHAMPIX 0,5 mg filmom obloženu tabletu jedanput na dan.
English: Varenicline is highly selective and binds more potently to the α4β2 receptor subtype (Ki=0.15 nM) than to other common nicotinic receptors (α3β4 Ki=84 nM, α7 Ki= 620 nM, α1βγδ Ki= 3,400 nM), or to non-nicotinic receptors and transporters (Ki > 1µM, except to 5-HT3 receptors: Ki=350 nM).
Croatian: Vareniklin je visoko selektivan i jače se veže za receptorski podtip α4β2 (Ki=0,15 nM) nego za ostale uobičajene nikotinske receptore (α3β4 Ki=84 nM, α7 Ki= 620 nM, α1βγδ Ki= 3400 nM), odnosno nenikotinske receptore i prijenosnike (Ki > 1µM, osim za 5-HT3 receptore: Ki=350 nM).
English: The results for the 4W CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) are shown in the following table:
Croatian: Rezultati za 4W CQR (od 9. do 12. tjedna) i stopa CA (od 9. do 52. tjedna) prikazani su u sljedećoj tablici:
English: A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1).
Croatian: Umjerena količina podataka u trudnica ukazuje da vareniklin ne uzrokuje malformacije i da nema fetalni/neonatalni toksični učinak (vidjeti dio 5.1).
English: The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1 - 3:
Croatian: Preporučena doza je 1 mg vareniklina dvaput na dan nakon jednotjedne titracije prema sljedećem rasporedu:
English: This study showed the benefit of an additional 12-week treatment with CHAMPIX 1 mg twice daily for the maintenance of smoking cessation compared to placebo; superiority to placebo for CA was maintained through week 52.
Croatian: Ovo je ispitivanje pokazalo korist dodatnih 12 tjedana liječenja lijekom CHAMPIX u dozi od 1 mg dvaput na dan u svrhu održavanja apstinencije od pušenja u usporedbi s placebom: superiornost u odnosu na placebo s obzirom na udio CA održana je do 52. tjedna.
English: For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1).
Croatian: U bolesnika koji su uspješno prestali pušiti na kraju 12 tjedana, može se razmotriti dodatni 12-tjedni ciklus liječenja lijekom CHAMPIX u dozi od 1 mg dvaput na dan za održavanje apstinencije (vidjeti dio 5.1).
English: Two thousand six hundred nineteen (2619) patients received CHAMPIX 1 mg BID (titrated during the first week), 669 patients received bupropion 150 mg BID (also titrated) and 684 patients received placebo.
Croatian: Dvije tisuće šesto devetnaest (2619) bolesnika primalo je CHAMPIX u dozi od 1 mg dvaput na dan (nakon titracije tijekom prvog tjedna), 669 bolesnika primalo je bupropion u dozi od 150 mg dvaput na dan (također nakon titracije), a 684 bolesnika primala su placebo.
English: The third study reported no difference in risk of psychiatric adverse events diagnosed during an emergency department visit or inpatient admission between varenicline users and bupropion users (HR 0.85; 95% CI: 0.55-1.30).
Croatian: U trećem ispitivanju nije prijavljena razlika u riziku od psihijatrijskih štetnih događaja dijagnosticiranih tijekom posjeta hitnoj službi ili bolničkom prijemu između korisnika vareniklina i bupropiona (HR 0,85; 95% CI: 0,55-1,30).
English: A large randomised, double-blind, active and placebo-controlled study was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo.
Croatian: Provedeno je veliko, randomizirano, dvostruko slijepo ispitivanje kontrolirano djelatnom tvari i placebom kako bi se usporedio rizik od ozbiljnih neuropsihijatrijskih događaja u bolesnika sa ili bez psihijatrijskog poremećaja u anamnezi liječenih zbog prestanka pušenja vareniklinom, bupropionom, flasterom za nikotinsku zamjensku terapiju (engl. nicotine replacement therapy, NRT) ili placebom.
English: You should ask your doctor or pharmacist for advice before taking CHAMPIX.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete CHAMPIX.
English: These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Croatian: Oni uključuju promjene raspoloženja (poput osjećaja depresije, razdražljivosti, frustracije ili tjeskobe), nesanicu, poteškoće s koncentracijom, smanjenu brzinu srčanih otkucaja i pojačan tek ili povećanje tjelesne težine.
English: At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.
Croatian: Na kraju liječenja je u 3% bolesnika prestanak uzimanja lijeka CHAMPIX bio povezan s povećanom razdražljivošću, željom za pušenjem, depresijom i/ili nesanicom.
English: The 4W-CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) from studies 1 and 2 are included in the following table:
Croatian: 4W-CQR (od 9. do 12. tjedna) i stopa CA (od 9. do 52. tjedna) u ispitivanjima 1 i 2 prikazani su u sljedećoj tablici:
English: Therefore, varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Croatian: Stoga nije vjerojatno da bi vareniklin mogao izmijeniti farmakokinetiku onih tvari koje se prvenstveno metaboliziraju pomoću enzima citokroma P450.
English: In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations.
Croatian: Ispitivanja in vitro pokazuju da vareniklin pri terapijskim koncentracijama ne inhibira bubrežne transportne proteine u ljudi.
English: Patients who cannot tolerate adverse reactions of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
Croatian: U bolesnika koji ne mogu podnijeti nuspojave lijeka CHAMPIX, doza se može privremeno ili trajno smanjiti na 0,5 mg dvaput na dan.
English: In addition, independent observational studies have not supported an increased risk of serious neuropsychiatric events in patients treated with varenicline compared to patients prescribed nicotine replacement therapy (NRT) or bupropion.
Croatian: Uz to, neovisna opservacijska ispitivanja nisu poduprla povećani rizik od ozbiljnih neuropsihijatrijskih događaja u bolesnika liječenih vareniklinom u usporedbi s bolesnicima kojima je propisana nikotinska zamjenska terapija ili bupropion.
English: Across both Studies 1 and 2 during active treatment, craving and withdrawal were significantly reduced in patients randomised to CHAMPIX in comparison with placebo.
Croatian: U oba su ispitivanja (1 i 2) tijekom aktivnog liječenja žudnja i simptomi ustezanja bili značajno smanjeni u bolesnika randomiziranih u skupinu koja je primala CHAMPIX u odnosu na skupinu koja je primala placebo.
English: CA* wk 13-24 70.6% 49.8% 20.8% CA* wk 13-52 44.0% 37.1% 6.9%
Croatian: CA* 13.-24. tjedan 70,6% 49,8% 20,8%
English: The fourth study showed no evidence of a higher risk of fatal and non-fatal self- harm (HR of 0.88; 95% CI: 0.52-1.49) in patients prescribed varenicline compared to patients prescribed NRT.
Croatian: U četvrtom ispitivanju nisu utvrđeni dokazi većeg rizika od samoozljeđivanja sa smrtnim ishodom ili bez njega (HR od 0,88; 95% CI: 0,52-1,49) u bolesnika kojima je propisan vareniklin u usporedbi s bolesnicima kojima je propisana nikotinska zamjenska terapija.
English: Subjects with mild-moderate chronic obstructive pulmonary disease (COPD) The efficacy and safety of CHAMPIX (1 mg twice daily) for smoking cessation in subjects with mild-moderate COPD was demonstrated in a randomised double-blind placebo-controlled clinical trial.
Croatian: Ispitanici s blagom do umjerenom kroničnom opstruktivnom plućnom bolešću (KOPB) Djelotvornost i sigurnost lijeka CHAMPIX (1 mg dvaput na dan) u odvikavanju od pušenja u ispitanika s blagim do umjerenim KOPB-om dokazana je u randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju.
English: No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment.
Croatian: Ne preporučuje se prilagođavati dozu zbog istodobne primjene cimetidina u ispitanika s normalnom bubrežnom funkcijom ili u bolesnika s blagim do umjerenim oštećenjem bubrega.
English: Non-psychiatric Cohort N=3984
Croatian: Nepsihijatrijska kohorta N=3984
English: The primary endpoint of the study was the CO-confirmed, 4-week Continuous Quit Rate (4W CQR) from week 9 through week 12 and a key secondary endpoint was the Continuous Abstinence (CA) from Week 9 through Week 52.
Croatian: Primarna mjera ishoda ispitivanja bila je stopa kontinuiranog prestanka pušenja tijekom 4 tjedna (4W CQR), od 9. do 12. tjedna, a ključna sekundarna mjera ishoda bila je kontinuirana apstinencija (CA) od 9. do 52. tjedna.
English: Day 1 - 3
Croatian: 1. - 3. dan
English: During the active treatment period, the incidence of suicide-related events was similar between the varenicline-treated and the placebo-treated subjects (11 vs. 9.3%, respectively).
Croatian: Tijekom razdoblja aktivnog liječenja incidencija događaja povezanih sa samoubojstvom bila je podjednaka u ispitanika koji su primali vareniklin i onih koji su primali placebo (11 naspram 9,3%).
English: CA was defined as the proportion of all subjects treated who did not smoke (not even a puff of a cigarette) from Week 9 through Week 52 and did not have an exhaled CO measurement of > 10 ppm.
Croatian: CA je definirana kao udio svih liječenih ispitanika koji nisu pušili (čak niti jedan dim cigarete) između 9. i 52. tjedna i u kojih izmjerena količina CO u izdisaju nije bila >10 ppm.