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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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zbadać coś, rozpatrywać coś começar a aprender
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podziwiać kogoś, zapatrywać sie w kogoś começar a aprender
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começar a aprender
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começar a aprender
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to look through something
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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investigational treatment
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começar a aprender
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começar a aprender
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w kontrolowanym środowisku (warunkach) começar a aprender
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under controlled environment
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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mylący, wprowadzający w błąd começar a aprender
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zaprzestanie przyjmowania leku começar a aprender
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começar a aprender
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começar a aprender
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kryteria włączenia i wyłączenia começar a aprender
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inclusion and exclusion criteria
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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określony, wyszczególniony começar a aprender
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começar a aprender
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começar a aprender
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a tracksuit/ a team uniform
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começar a aprender
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być podwójnie szczęsliwym começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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środek poprawia perspektywy nawrotu choroby começar a aprender
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an agent improvs the outlook of relapse disease
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começar a aprender
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começar a aprender
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porównać skuteczność i bezpieczeństwo começar a aprender
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to compare efficacy and safety
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começar a aprender
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começar a aprender
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określić u osoby z rozpoznaną chorobą começar a aprender
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to determine in subject with this diagnosed illness
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cofnąć zgodę organu regulacyjnego começar a aprender
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revoke regulatory approval
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começar a aprender
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Handlować, wprowadzać na rynek começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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naskórkowy czynnik wzrostu começar a aprender
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pierwszorzędowy punkt końcowy- przeżycie całkowite começar a aprender
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primary endpoint - overall survival
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começar a aprender
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osiągnąć cel drugorzędowego punktu końcowego começar a aprender
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reach the goal of the secondary endpoint
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começar a aprender
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progression free survival
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ogólny wskaźnik odpowiedzi começar a aprender
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começar a aprender
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przyłapać, zająć (np. miejsce) começar a aprender
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uzyskać nominację (przytaknięcie) começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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começar a aprender
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terapia podstawowa/standard opieki começar a aprender
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background therapy/ standard of care
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leczenie kontrolne lub standardowe jest porównywane z leczeniem eksperymentalnym começar a aprender
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the control or standard treatment is compared against the investigational treatment
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dwie lub więcej interwencji w określonej kolejności começar a aprender
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two or more interventions in a specific order
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pacjent może przerwać przyjmowanie badanego leku z dowolnego powodu começar a aprender
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patient can stop taking study drug for any reason
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tylko farmaceuta biorący udział w badaniu wie, jaki badany lek otrzymuje uczestnik começar a aprender
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only the study pharmacist knows what study medication a participiant is receving
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przedwczesne wycofanie się pacjenta z badania começar a aprender
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premature patient withdrawal from a trial
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começar a aprender
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wymagania, jakie musi spełnić pacjent começar a aprender
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the requirements that patient must meet
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kryteria kwalifikacyjne obejmują zarówno kryteria włączenia, jak i kryteria wykluczenia começar a aprender
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eligibility criteria include both inclusion criteria and exclusion criteria
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formularz świadomej zgody começar a aprender
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ochotnicy przystępują do badania po uzyskaniu świadomej zgody começar a aprender
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voluntieers entry into the trial after informed consent has been obtained
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enrollment to także liczba uczestników badania klinicznego começar a aprender
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enrollment is also the number of participants in a clinical trial
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określenie kwalifikowalności przedmiotu começar a aprender
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determination of subject eligibility
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começar a aprender
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ekspozycja podmiotu leczonego começar a aprender
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exposure of subject to treatment
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começar a aprender
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Food and Drug Administration
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wskazanie - choroba, objaw lub szczególny zestaw okoliczności, które sprawiają, że lek jest zalecany começar a aprender
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indication - disease, symptom or particular set of circumstances that made medication advisable
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Świadoma zgoda służy wyjaśnieniu potencjalnego uczestnika badania klinicznego começar a aprender
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Informed consent is used to explain the clinical trial potential subject
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Jego celem jest ochrona uczestnika começar a aprender
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Its purpose is to protect the participiant
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personel przegląda szczegóły z uczestnikiem i odpowiada na wszelkie pytania começar a aprender
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the staff reviews the details with subject and answers any questions
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Formularz świadomej zgody ma być jasny i łatwy do zrozumienia começar a aprender
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informed consent form is designed to be clear and easy to understand
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jeśli ktoś zdecyduje się zapisać, musi podpisać ICF, aby potwierdzić, że rozumie começar a aprender
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if somebody to decide to enroll, he has to sign ICF to acknoledge that he understand
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może wycofać się w dowolnym momencie i z dowolnego powodu começar a aprender
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he can withdraw at any time and for any reason
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Instytucjonalna Rada Rewizyjna / Niezależna Komisja Etyki começar a aprender
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Institutional Review Board / Independent Ethics Committee
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grupa osób, która jest formalnie wyznaczona do przeglądu i monitorowania wszystkich badań z udziałem ludzi começar a aprender
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group of people which is formally designated to review and monitor all trials involving humans
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są one na miejscu, aby zapewnić nadzór etyczny i zminimalizować ryzyko começar a aprender
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they are in place to provide ethical oversightand to minimize risk
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badanie interwencyjne = badanie kliniczne começar a aprender
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interventional study = clinical trial
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uczestnik otrzyma jedną lub więcej interwencji, zgodnie z protokołem começar a aprender
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participant receive one or more intervention, according to the protocol
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badacz może ocenić wpływ interwencji na stan zdrowia começar a aprender
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investigator can evaluate the effects of the intervention on a health condition
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badanie obserwacyjne bada wyniki zdrowotne wśród grup ludzi começar a aprender
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an observational study investigates health outcomes amongst groups of people
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miara wyniku - ustalony pomiar opisany w protokole, używany do oceny efektu começar a aprender
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outcome measure - set measurement that is described in the protocol and is used to evaluate the effect
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zaniedbanie, postępowanie niezgodne z protokołem começar a aprender
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começar a aprender
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different severity of a disease
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placebo jest substancją nieaktywną começar a aprender
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placebo is an inactive substance
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começar a aprender
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placebo ma wyglądać jak leczenie eksperymentalne começar a aprender
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placebo is made to look like the investigational treatment
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służy do porównania rzeczywistego leczenia z oceną skuteczności começar a aprender
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it is used to compare the actual treatment against to evaluate effectiveness
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começar a aprender
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odpowiada za kierownictwo naukowo-techniczne começar a aprender
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is responsible for the scientific and technical direction
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protokół to pisemny plan badania, na którym opiera się badanie kliniczne começar a aprender
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protocol is written study plan which the clinical trial is based on
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harmonogram testów, procedur, leków i dawek, które mają być podawane começar a aprender
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the schedule of tests, procedures, medications, and dosage to be administrated
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pracownik badań klinicznych (CRA) começar a aprender
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clinical research associate (CRA)
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começar a aprender
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nadanie unikalnego numeru começar a aprender
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to assigne a unique number
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começar a aprender
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