natgillin/translations-raw huggingface dataset:
1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box. 
1 plastenka z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov) pakirana v kartonski škatli.
12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box. 
12 plastenk z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov) pakiranih v kartonski škatli.
1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses). 
1 plastenka z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov).
12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses). 
12 plastenk z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov).
4.6 Adverse reactions (frequency and seriousness) 
4.6 Neželeni učinki (pogostost in resnost) Prehodna rdečina ali oteklina (do 4 cm), ki jo povzroča postopek injiciranja, je zelo pogosta.
Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc. 
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Boehringer Ingelheim Vetmedica GmbH
Very little detailed information is available from the post-marketing setting. 
Iz obdobja trženja je na voljo zelo malo podrobnih informacij.
• Non-clinical 
• Neklinični vidiki
The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated. 
Odbor CHMP je menil, da v skladu s členom 12 Uredbe (ES) št. 726/2004 varnost zgoraj navedenega zdravila ni bila ustrezno ali zadovoljivo dokazana.
In addition, there is at least one literature case report of arrhythmia. 
Poleg tega obstaja vsaj eno poročilo iz literature o primeru aritmije.
However, no correction for multiplicity was performed when evaluating individual doses. 
Vendar pri oceni posameznih odmerkov ni bil izveden popravek mnogoterosti.
As 4423 patients were exposed to Iloperidone, this accounts for 0.14% of all treated patients. 
Ker je bilo iloperidonu izpostavljenih 4 423 bolnikov, to pomeni 0,14 % vseh zdravljenih bolnikov.
Overall summary of the scientific evaluation of Fanaptum 
Splošni povzetek znanstvenega vrednotenja zdravila Fanaptum
Late onset of action is regarded as a considerable drawback. 
Zapoznel začetek delovanja velja za znatno pomanjkljivost.
There were 33 deaths of which 3 patients died during sleep, 6 were sudden deaths, and 6 cases were of cardiac origin. 
Prišlo je do 33 smrtnih primerov, pri katerih so trije bolniki umrli med spanjem, šest nenadnih smrti in šest primerov kardiološkega izvora.
This means that, from a precautionary approach, patients could not safely be concomitantly treated with a large number of other medicines. 
S previdnostnega vidika to pomeni, da bolniki ne morejo biti sočasno varno zdravljeni z velikim številom drugih zdravil.
Thus, Study 3101 was the only positive short-term study exclusively conducted in schizophrenia patients. 
Zato je bila študija 3101 edina pozitivna kratkoročna študija, izvedena izključno pri bolnikih s shizofrenijo.
It is not considered that the risk minimization measures proposed would appropriately address the risk identified in this specific case. 
Velja, da predlagani ukrepi za zmanjševanje tveganja v tem posebnem primeru ne bi ustrezno odpravili ugotovljenega tveganja.
The efficacy of daily doses lower than 24 mg was insufficiently characterised. 
Učinkovitost dnevnih odmerkov, manjših od 24 mg, ni bila zadostno opredeljena.
Several approaches to various data sets support the notion that full efficacy of Fanaptum is not achieved before Week 3. 
Več pristopov k različnim naborom podatkov podpira stališče, da zdravilo Fanaptum svoje polne učinkovitosti ne doseže pred 3. tednom.
However, post-hoc analyses presented in support of this argument were based on patients completing at least 2 weeks of treatment, which is a different population from that originally assigned to treatment. 
Vendar so naknadno predstavljene analize v podporo tej trditvi temeljile na bolnikih, ki so zaključili vsaj dvotedensko zdravljenje, kar pa ni enaka populacija kot tista, ki ji je bilo zdravljenje prvotno dodeljeno.
Iloperidone is also associated with a clinically significant body weight increase. 
Iloperidon je povezan tudi s klinično pomembnim povečanjem telesne mase.
Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Fanaptum. 
Odbor CHMP je zato priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Fanaptum.
Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way. 
Proučeni so bili fizikalno-kemijski in biološki vidiki, pomembni za enotno klinično učinkovitost zdravila, ki so zadovoljivo nadzorovani.
Additional data has been provided from the open-label Study US01 comparing two ways of switching to Fanaptum from another treatment, gradual (over two weeks) or immediate. 
Dodatni podatki so bili pridobljeni iz odprte študije US01, v kateri so primerjali dva načina prehoda z drugega zdravljenja na zdravilo Fanaptum: postopnega (v več kot dveh tednih) ali takojšnjega.
An active comparator was included in studies 3000 (Haloperidol), 3004 and 3005 (Risperidone), and 3101 (Ziprasidone). 
Aktivno primerjalno zdravilo je bilo vključeno v študije 3000 (haloperidol), 3004 in 3005 (risperidon) ter 3101 (ziprasidon).
Iloperidone and the metabolite P88 shows relatively high affinity for hERG channel (IC50 of 12.4 and 24.1 ng/mL). 
Iloperidon in presnovek P88 kažeta sorazmerno visoko afiniteto do kanala hERG (IC50 12,4 in 24,1 ng/ml).
Therefore, and taking into account the overall safety and efficacy profile of Iloperidone a patient population cannot be identified where the benefit of treatment is considered to outweigh the major safety concerns. 
Posledično ob upoštevanju celotnega varnostnega profila in profila učinkovitosti iloperidona ni mogoče določiti populacije bolnikov, pri kateri bi veljalo, da koristi zdravljenja odtehtajo glavne pomisleke o varnosti;
In addition, it has shown a delayed onset of action, which is a significant concern in the treatment of acute exacerbation of schizophrenia. 
Poleg tega se je izkazalo, da ima zapoznel začetek delovanja, kar je pri zdravljenju akutnega poslabšanja shizofrenije pomemben pomislek.
Iloperidone is associated with extrapyramidal effects, but to a modest degree. 
Iloperidon je povezan z ekstrapiramidnimi učinki, vendar do zmerne stopnje.
Thus, mechanisms that could potentially mitigate the prominent pro-arrhythmogenic potential of iloperidone are not present. 
Zato mehanizmi, ki bi lahko morebiti zmanjšali največji proaritmogeni potencial iloperidona, niso prisotni.
• Quality 
• Kakovost
However, Study 3004 also included patients with schizoaffective disorder and efficacy was not demonstrated in the schizophrenia subgroup. 
Vendar so bili v študijo 3004 vključeni tudi bolniki s shizoafektivno motnjo in v podskupini bolnikov s shizofrenijo učinkovitost ni bila dokazana.
Based on the above, the risk-benefit balance of Iloperidone is considered negative. 
se šteje na podlagi zgoraj navedenega razmerje med tveganji in koristmi iloperidona za negativno.
Thus, efficacy has not been convincingly established for 12 mg/day dose. 
Zato učinkovitost za odmerek 12 mg/dan ni bila prepričljivo dokazana.
Furthermore, risperidone was still associated with a numerically superior effect estimate - even for patients treated for >2 weeks. 
Poleg tega je bilo zdravilo risperidon še vedno povezano s številčno superiorno oceno učinka - tudi pri bolnikih, zdravljenih manj kot dva tedna.
The short-term efficacy of Fanaptum in patients with an acute episode of schizophrenia has been mainly characterised in five placebo-controlled studies. 
Kratkoročni učinek zdravila Fanaptum pri bolnikih z akutno epizodo shizofrenije je bil v glavnem opredeljen v petih s placebom nadzorovanih študijah.
Similarly, at Week 2 it was 4.2 for ziprasidone i.e. almost full efficacy, whereas the difference was still only 2.8 for Fanaptum. 
Podobno je v 2. tednu razlika pri ziprasidonu znašala 4,2 točke, kar je skoraj polna učinkovitost, za zdravilo Fanaptum pa je razlika še vedno bila le 2,8.
The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SmPC. 
Kakovost zdravila Fanaptum je bila ocenjena za sprejemljivo, če se uporablja skladno s pogoji, opredeljenimi v povzetku glavnih značilnosti zdravila.
Annex I Scientific conclusions and grounds for refusal presented by the European Medicines Agency 
Priloga I Znanstveni zaključki in podlaga za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
Compared to other antipsychotics, Fanaptum has a late onset of action. 
V primerjavi z drugimi antipsihotiki začne zdravilo Fanaptum delovati zapoznelo.
In consideration of the complex causal chain linking the exposure to Iloperidone to events such as Torsade de Pointes, including unknown and stochastic elements and elements subject to an unpredictable variability, it is considered that the risk minimization measures proposed would not adequately address in clinical practice the risk identified. 
Ob upoštevanju zapletene vzročne verige, ki povezuje izpostavljenost iloperidonu z dogodki, kot so pojav torsade de pointes, vključno z neznanimi in stohastičnimi elementi ter elementi, odvisnimi od nepredvidljive spremenljivosti, velja, da predlagani ukrepi za zmanjševanje tveganj v klinični praksi ne bi zadostno odpravili ugotovljenih tveganj.
This indicates that Iloperidone could cause QT prolongation. 
To kaže, da lahko iloperidon povzroči podaljšanje intervala QT.
PK-PD analyses presented were fundamentally flawed in that placebo patients were included with an assigned value of zero - impacting the results of the analysis. 
Predstavljene analize PK-PD so imele temeljno napako: bolniki, ki so prejemali placebo, so bili vključeni z dodeljeno vrednostjo nič, kar je vplivalo na rezultate analize.
The overall nonclinical safety pharmacology data point to a risk of QT prolongation (hERG blockade, APD prolongation in dog Purkinje fibres). 
Skupni neklinični farmakološki podatki o varnosti kažejo na tveganje podaljšanja intervala QT (blokado hERG, podaljšanje APD v Purkynějevih vlaknih pri psih).
However, the exposure in the dog studies appears to be lower than in the clinical setting, and therefore the absence of any QT prolongation in the in vivo dog studies is not considered to alleviate the concerns raised based on the in vitro studies. 
Vendar se izpostavljenost v študijah pri psih zdi nižja kot v kliničnem okolju, zato odsotnost morebitnega podaljšanja intervala QT v študijah pri psih in vivo ne zadošča za odpravljanje izraženih pomislekov na podlagi študij in vitro.
However, as the randomised withdrawal study by design has to include the responders only i.e., the population is enriched, the magnitude of the effect can only be derived from the short term studies. 
Ker pa mora randomizirana študija z naknadno prekinitvijo zdravljenja zaradi svoje zasnove vključevati samo bolnike z odzivom, kar pomeni, da je populacija obogatena, je mogoče obseg učinka ugotoviti le iz kratkoročnih študij.
However, this study - with an open label design and lacking of a group of patients randomised to a treatment other than Fanaptum or to placebo - was not designed to establish efficacy in patients switching from another treatment. 
Vendar pa ta študija (z odprto zasnovo in brez skupine bolnikov, randomiziranih v zdravljenje, ki bi bilo različno od zdravljenja z zdravilom Fanaptum ali s placebom) ni bila zasnovana za ugotavljanje učinkovitosti pri bolnikih, ki so prešli na to zdravljenje z drugega zdravljenja.
Hence, the safety of Iloperidone has not been sufficiently demonstrated. 
Zato varnost iloperidona ni bila zadostno dokazana;
The main safety issue with Iloperidone is that it causes QTc prolongation with the subsequent risks of arrhythmia and sudden death. 
Glavna težava z varnostjo iloperidona je, da povzroča podaljšanje intervala QTc z naknadnim tveganjem aritmije in nenadne smrti.
In the clinical trial programme, 4.5% of the patients treated with iloperidone regardless of dose (4-24 mg/day) had an increase more than 60 msec at some time point. 
V programu kliničnega preskušanja je povečanje pri 4,5 % bolnikov, zdravljenih z iloperidonom ne glede na odmerek (4-24 mg/dan) v določenem trenutku znašalo več kot 60 ms.
In this study, the PANSS reduction with Iloperidone 24 mg differed in a statistically significant manner from placebo at Week 4 but the magnitude of the effect was modest with a reduction of approximately 5 points on the PANNS-T scale compared to placebo. 
V tej študiji se je zmanjšanje po ocenjevalni lestvici PANSS z iloperidonom v odmerku 24 mg v 4. tednu na statistično pomemben način razlikovalo od placeba, vendar je bil obseg učinka zmeren: v primerjavi s placebom je bilo zmanjšanje prisotno pri približno 5 točkah na ocenjevalni lestvici PANNS-T.
• Furthermore, Iloperidone has a modest efficacy. 
• iloperidon je bil poleg tega zgolj zmerno učinkovit.
Unfortunately, the CYP2D6 genotype was not known in the patients that died during the clinical studies or post-marketing. 
Žal pri bolnikih, ki so umrli med kliničnimi študijami ali v obdobju trženja, ni bil znan genotip CYP2D6.
Furthermore, as the metabolism of iloperidone relies heavily on CYP3A4 and CYP2D6, this creates the potential of increased exposure to the drug as a consequence of drug-drug interactions and genetic polymorphisms. 
Ker je poleg tega presnova iloperidona v glavnem odvisna od encimov CYP3A4 in CYP2D6, se pojavi možnost povečane izpostavljenosti zdravilu kot posledica interakcij zdravila z zdravilom in genskih polimorfizmov.
The Applicant argued that the apparent difference between Fanaptum and risperidone could be partially due to a greater number of patients on Fanaptum discontinuing early due to lack of efficacy during titration. 
Predlagatelj je trdil, da je očitna razlika med zdraviloma Fanaptum in risperidon lahko delno nastala zaradi večjega števila bolnikov, zdravljenih z zdravilom Fanaptum, ki so zaradi neučinkovitosti med titracijo predčasno prenehali zdravljenje.
For instance, in Study 3101 where full effect vs placebo would correspond to a reduction of 5 PANSS-T points, it is remarkable that the difference at Week 1 was already 2.4 for ziprasidone, whereas it was 0.1 for Fanaptum. 
V študiji 3101, pri kateri polni učinek v primerjavi s placebom ustreza zmanjšanju za 5 točk pri ocenjevanju z lestvico PANSS-T, je na primer izjemno, da je razlika v 1. tednu za ziprasidon znašala že 2,4 točke, za zdravilo Fanaptum pa 0,1.
Acknowledging the relationship between QTc prolongation (and the connected risks) and exposure, the Applicant proposed for this re-examination a contraindication in CYP2D6 poor metabolisers or in those patients with unknown CYP2D6 metaboliser status, and for concomitant use with drugs that are known strong CYP2D6 or CYP3A4 inhibitors. 
Predlagatelj je ob priznavanju razmerja med podaljšanjem intervala QTc (in povezanih tveganj) in izpostavljenosti za ta ponovni pregled predlagal kontraindikacijo pri osebah, ki slabo presnavljajo prek encima CYP2D6, ali pri bolnikih, pri katerih stanje presnavljanja prek encima CYP2D6 ni znano, in sočasno uporabo z zdravili, za katere je znano, da so močni zaviralci CYP2D6 ali CYP3A4.
For example, the proposal to perform ECGs at the estimated Tmax could miss the actual Tmax due to intrinsic or extrinsic factors, leading to an underestimation of the QTcF prolongation. 
Predlog za opravljanje EKG pri ocenjeni vrednosti Tmax bi lahko zaradi intrinzičnih ali ekstrinzičnih dejavnikov zgrešil dejansko vrednost Tmax, zaradi česar bi bilo podaljšanje intervala QTcF podcenjeno.
In addition, whether the correct implementation of the complete set of measures would be feasible in all clinical settings is questionable due to practical reasons (for example the availability of suitably trained cardiologists), as also mentioned by the Experts in the ad-hoc meeting. 
Poleg tega je iz praktičnih razlogov (na primer razpoložljivosti primerno usposobljenih kardiologov) vprašljivo, ali bi bilo mogoče v vseh kliničnih okoljih doseči pravilno uvedbo celotnega nabora ukrepov, kar so navedli tudi strokovnjaki na priložnostnem sestanku.
Of those, three - B202, 3000, and 3005 - failed to show superiority over placebo according to their pre-specified primary endpoints and analysis plans, and two3004 and 3101 - met their pre-specified criteria for superiority over placebo. 
Od teh študij v treh (B202, 3000, in 3005) niso dokazali superiornosti v primerjavi s placebom glede na njihove predhodno določene opazovane dogodke in načrte analize, v dveh (3004 in 3101) pa so bila izpolnjena predhodno določena merila za superiornost v primerjavi s placebom.
In conclusion, Iloperidone has a substantial arrhythmogenic potential, which becomes obvious if all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and also the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing) are taken into account. 
Zaključek je, da ima iloperidon znaten aritmogeni potencial, ki postane očiten z upoštevanjem vseh razpoložljivih nekliničnih in kliničnih podatkov (vključno s temeljito študijo intervala QTc, celotnim kliničnim programov ter tudi s primeri s srcem povezane/nenadne nepojasnjene smrti v kliničnih preskušanjih in obdobju trženja).
• Considering all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing), Iloperidone has a substantial and exposure-dependent arrhythmogenic potential. 
• z upoštevanjem vseh razpoložljivih nekliničnih in kliničnih podatkov (vključno s temeljito študijo intervala QTc, celotnim kliničnim programov ter tudi s primeri s srcem povezane/nenadne nepojasnjene smrti v kliničnih preskušanjih in obdobju trženja), ima iloperidon znaten in od izpostavljenosti odvisen aritmogeni potencial.
The indirect comparison for efficacy proposed by the Applicant does not fulfil the methodological standards of systematic reviews (for instance, comprehensive search strategy, transparent and replicable inclusion criteria), and this limits the reliability of the conclusions that can be drawn from it. 
Posredna primerjava učinkovitosti, ki jo je predlagal predlagatelj, ne izpolnjuje metodoloških standardov sistematičnih pregledov (na primer strategije izčrpnega iskanja, preglednih in ponovljivih meril vključitve), zato je zanesljivost sklepov, ki jih je mogoče iz nje izpeljati, omejena.
The arrhythmogenicity of Iloperidone is mechanistically related to its selective inhibition of cardiac potassium channels leading to delayed repolarization which is seen in the characteristic action potential prolongations in ventricular dog Purkinje fibres. 
Aritmogenost iloperidona je mehansko povezana z njegovim selektivnim zaviranjem kalijevih kanalčkov v srcu, kar zakasni depolarizacijo, vidno v značilnih podaljšanjih akcijskega potenciala pri ventrikularnih Purkynějevih vlaknih pri psih.
Doses as low as 4-8 mg/day appeared effective in one study (3004), and in some studies doses of 12 mg/day (3000), 10-16 mg/day (3004) or 12-16 mg/day (3005) likewise showed superiority to placebo. 
V eni študiji (3004) so se odmerki 4-8 mg/dan zdeli učinkoviti, v nekaterih študijah pa je bila pri odmerkih 12 mg/dan (v študiji 3000), 10-16 mg/dan (v študiji 3004) ali 12-16 mg/dan (v študiji 3005) podobno dokazana superiornost v primerjavi s placebom.
In reviewing the results of the thorough QTc study, out of 94 patients exposed to Iloperidone at different doses without metabolic inhibition in the Secondary QTc population 43 and 2 patients respectively developed a prolongation of the QTcF of more than 30 and 60 msec. 
Pri pregledu rezultatov temeljite študije intervala QTc se je od 94 bolnikov, ki so bili izpostavljeni iloperidonu v različnih odmerkih brez zaviranja presnove v sekundarni populaciji QTc, pri 43 oziroma pri 2 bolnikih razvilo podaljšanje intervala QTcF, ki je znašalo več kot 30 in 60 ms.
Although comparative efficacy was not the primary objective of those studies, the magnitude of effect of Fanaptum appeared similar to Ziprasidone but compared negatively with 
Čeprav primarni cilj teh študij ni bila primerjalna učinkovitost, se je obseg učinka zdravila Fanaptum zdel podoben obsegu učinka zdravila ziprasidon, v primerjavi z zdraviloma haloperidol in risperidon pa je bil negativen.
In conclusion, Iloperidone has a modest efficacy. 
Zaključek je, da je iloperidon zmerno učinkovit.
Iloperidone has a high affinity to the hERG channels and causes QTc exposure-dependent prolongation. 
Iloperidon ima visoko afiniteto do kanala hERG in povzroča podaljšanje intervala QTc, ki je odvisno od izpostavljenosti.
As mentioned for the one related to Efficacy, the indirect comparison for Akathisia proposed by the Applicant does not fulfil the methodological standards of systematic reviews (for instance, comprehensive search strategy, transparent and replicable inclusion criteria), and this limits the reliability of the conclusions that can be drawn from it. 
Kot je bilo že navedeno za primerjavo, povezano z učinkovitostjo, posredna primerjava akatizije, ki jo je predlagal predlagatelj, ne izpolnjuje metodoloških standardov sistematičnih pregledov (na primer strategije izčrpnega iskanja, preglednih in ponovljivih meril vključitve), zato je zanesljivost sklepov, ki jih je mogoče iz nje izpeljati, omejena.
However, the metabolism of Iloperidone is still of concern in relation to its exposure-dependent risks. 
Vendar je presnova iloperidona v povezavi z njegovimi tveganji, odvisnimi od izpostavljenosti, še vedno vprašljiva.
In the thorough QTc study (Study CILO522A2328), the mean change in QTcF from baseline to steady state at Tmax was approximately 9 msec in the 8 mg and 12 mg BID groups and was 15.4 msec in the group receiving Iloperidone 24 mg q.d. 
V temeljiti študiji intervala QTc (študiji CILO522A2328) je srednja vrednost spremembe intervala QTcF od izhodišča do stanja dinamičnega ravnovesja pri Tmax znašala približno 9 ms v skupinah BID z odmerkoma 8 mg in 12 mg ter 15,4 ms v skupini, ki je prejemala 24-miligramski odmerek iloperidona enkrat na dan v primerjavi z 1,3 ms v skupini, ki je prejemala kvetiapin (negativno kontrolo).
Action potential prolongation was observed in ventricular dog Purkinje fibres, confirming the pro-arrhythmogenic potential of Iloperidone. 
Pri ventrikularnih Purkynějevih vlaknih pri psih so opazili podaljšanje akcijskega potenciala, kar potrjuje proaritmogeni potencial iloperidona.
It is currently unknown if Iloperidone can be safely administered with weak and/or moderate inhibitors of CYP2D6 and/or CYP3A4 given the likely variability of the efficiency of minor metabolic pathways. 
Trenutno ni znano, ali je zaradi verjetne spremenljivosti učinkovitosti manjših presnovnih poti mogoče iloperidon varno dajati s šibkimi in/ali zmernimi zaviralci CYP2D6 in/ali CYP3A4.
At least one fatal case could possibly have been preceded by ventricular arrhythmia and Torsades de Pointes. 
Pri vsaj enem smrtnem primeru sta se predhodno morda pojavila ventrikularna aritmija in pojav torsades de pointes (vrsta polimorfne ventrikularne tahikardije).
There were 6 cases of sudden deaths or deaths due to cardiac AE in the clinical trials. 
Pri kliničnih preskušanjih je bilo 6 primerov nenadne smrti ali smrti zaradi kardioloških neželenih učinkov.
In conclusion, there was no robust support for statements concerning dose-response relationship below 24 mg/day (the dose used in study 3101). 
Zaključek je, da za odmerke, manjše od 24 mg/dan (kar je odmerek, uporabljen v študiji 3101), ni zanesljive podpore za izjave v zvezi z razmerjem odmerek-odziv.