natgillin/translations-raw huggingface dataset:
I hver undersøgelse blev det primære endepunkt (andel af patienter med iPTH 250 pg/ml (26,5 pmol/l)) opnået af 41 %, 46 % og 35 % af de patienter, der blev behandlet med cinacalcet, sammenlignet med 4 %, 7 % og 6 % af patienterne i placebogruppen.
In each of the studies, the primary endpoint (proportion of patients with an iPTH  250 pg/ml ( 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
I hver undersøgelse blev det primære endepunkt (andel af patienter med iPTH 250 pg/ml (26,5 pmol/l)) opnået af 41%, 46% og 35% af de patienter, der blev behandlet med cinacalcet, sammenlignet med 4%, 7% og 6% af patienterne i placebogruppen.
In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
I hver undersøgelse blev omkring 300 pattegrise vaccineret med Porcilis PCV M Hyo, mens endnu en gruppe på 300 pattegrise fik en virkningsløs injektion.
In each study around 300 suckling piglets were vaccinated with Porcilis PCV M Hyo and a second group of around 300 suckling piglets received a dummy injection.
I hvert af fase III-studierne og den puljede analyse var middeltykkelsen af retina væsentlig mindre – og middelreduktionen fra baseline var væsentlig større – med OZURDEX (-207,9 mikrometer) sammenlignet med sham (-95,0 mikrometer) på dag 90 (p < 0,001, puljede data).
In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, and the mean reduction from baseline was significantly greater, with OZURDEX (-207.9 microns) compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data).
I hvert forsøg blev fire grupper med hver 6 fritter vaccineret intramuskulært med en AS03-adjuvans- vaccine indeholdende HA fra H5N1/A/Vietnam/1194/04 (NIBRG-14).
In each experiment, four groups of six ferrets were immunised intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
I hvert forsøg blev fire grupper med hver 6 fritter vaccineret intramuskulært med en AS03-adjuvans- vaccine indeholdende HA fra H5N1/A/Vietnam/1194/04 (NIBRG-14).
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
I hvert open label forlængelses forsøg blev patienterne randomiserede i forholdet 2:1 til at få enten Repatha plus standardbehandling (evolocumab-gruppen) eller standardbehandling alene (kontrolgruppen) i forsøgets første år.
In each extension study, patients were randomised 2:1 to receive either Repatha plus standard of care (evolocumab group) or standard of care alone (control group) for the first year of the study.
I høje doser (f.eks.
At high doses (e.g.
I høje doser (≥ 5 IE/kg/dag.) forårsager follitropin alfa en mindskelse af antallet af levedygtige fostre uden at være teratogent, og dystoci svarende til det, der er observeret ved urinderiveret menopausalt gonadotropin (hMG).
Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
I høje doser (≥ 5 IE/kg/dag.) forårsager follitropin alfa en mindskning af antallet af levedygtige fostre uden at være teratogent, og dystoci svarende til det, der er observeret ved urinær menopausal gonadotropin (hMG).
Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
I høje doser ( 5 IE/kg/dag.) forårsager follitropin alfa en mindskning af antallet af levedygtige fostre uden at være teratogent, og dystoci svarende til det, der er observeret ved urinær menopausal gonadotropin (hMG).
Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
I ikke kontrollerede undersøgelser, hvor lamivudin blev administreret før og under transplantation, blev der påvist effektiv suppression af HBV DNA og normalisering af ALAT.
In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
I ikke- kliniske in vitro assays og i in vivo tumormodeller har erlotinibs primære metabolitter OSI-420 og OSI-413, som dannes ved O-demetylering af sidekæderne, samme virkning som erlotinib.
The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
I ikke- kliniske studier med umeclidiniumbromid var resultaterne i overensstemmelse med dem, der typisk forbindes med den primære farmakologi af muskarinreceptorantagonister, og/eller lokal irritation.
In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
I ikke-blindet opfølgning på kliniske LEMTRADA-studier fik nogle patienter yderligere behandling "efter behov" med LEMTRADA ved dokumenteret fortsat MS-sygdomsaktivitet.
In open-label follow-up of LEMTRADA clinical trials, some patients received additional “as needed” treatment with LEMTRADA upon documented evidence of resumed MS disease activity.
I ikke-klinisk sikkerhedsfarmakologiske, generel toksicitets-, genotoksicitets- samt karcinogenecitets- forsøg sås ingen klinisk relevant virkning, med undtagelse af virkningen, som var forbundet med læge- midlets farmakologiske virkning.
In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies no clinically relevant effects have been observed, except those related to the pharmacological effect of the active substance.
I ikke-kliniske forsøg viste lacosamid i kombination med levetiracetam, carbamazepin, phenytoin, valproat, lamotrigin, topiramat eller gabapentin synergistiske eller additive antikonvulsive effekter.
In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects.
I ikke-kliniske modeller har elotuzumab vist synergistisk aktivitet, når det kombineres med lenalidomid eller bortezomib.
In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide or bortezomib.
I ikke-kliniske studier med umeclidinium og vilanterol, alene og i kombination, var resultaterne i overensstemmelse med dem, der typisk forbindes med den primære farmakologi af enten muskarinreceptorantagonister eller beta2-agonister, og/eller lokal irritation.
In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta2-adrenergic agonists respectively and/or local irritancy.
I iloprost-gruppen bedredes NYHA-klassen hos 26 % af patienterne (placebo: 15 %) (p=0,032), var uændret hos 67,7 % af patienterne (placebo: 76 %) og forværredes hos 6,3 % af patienterne (placebo: 9 %).
In the iloprost group the NYHA class was improved in 26% of patients (placebo: 15%) (p = 0.032), unchanged in 67.7% of patients (placebo: 76%) and deteriorated in 6.3% of patients (placebo: 9%).
I immunogenicitetsundersøgelsen gav Synflorix og sammenligningsvaccinen ensartede resultater for de fleste af de S. pneumoniae-polysakkarider, de havde til fælles.
In the immunogenicity study, Synflorix produced a similar response to the comparator vaccine for the majority of the S. pneumoniae polysaccharides they share in common.
I IMPAACT P1066 deltog også hiv-inficerede spædbørn og småbørn i alderen 4 uger til under 2 år, som tidligere havde fået antiretroviral terapi enten som forebyggende behandling til at forhindre overførsel af hiv-smitte fra mor til barn (PMTCT) og/eller som antiretroviral kombinationsterapi til behandling af hiv-infektion.
IMPAACT P1066 also enrolled HIV-infected, infants and toddlers 4 weeks to less than 2 years of age who had received prior antiretroviral therapy either as prophylaxis for prevention of mother to child transmission (PMTCT) and/or as combination antiretroviral therapy for treatment of HIV infection.
I ImproveR-registeret blev bolusdosering (uden efterfølgende infusion) observeret i klinisk praksis i EU.
In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
I in vitro blodprøver fra hest har firocoxib vist sig at være 222 til 643 gange mere selektiv over for COX-2 end over for COX-1.
“In “in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
I in vitro blodprøver fra heste har firocoxib vist sig at være 222 til 643 gange mere selektiv over for COX-2 end over for COX-1.
In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1
I in vitro blodprøver fra heste har firocoxib vist sig at være 222 til 643 gange mere selektiv over for COX-2 end over for COX-1.
In “in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
I in vitro forsøg hæmmede saxagliptin og dets hovedmetabolit hverken CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4 og saxagliptin og dets hovedmetabolit inducerede ikke CYP1A2, 2B6, 2C9 eller 3A4.
In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
I in vitro studier aftog den specifikke aktivitet af lipaser, der hydrolyserer glycerolphenylbutyrat, i følgende rækkefølge: pancreas-triglyceridlipase, carboxylester-lipase, og pancreaslipase–relateret protein 2.
In in vitro studies, the specific activity of lipases for glycerol phenylbutyrate was seen in the following decreasing order: pancreatic triglyceride lipase, carboxyl ester lipase, and pancreatic lipase–related protein 2.
I In vitro studier blev klonede humane kardiale kalium kanaler (HERG) inhiberet 30 % af de højeste testede koncentrationer af lopinavir/ritanovir, svarende til en lopinavir eksponering på 7 gange det totale og 15 gange det frie peak plasma niveau, som opnås i mennesker ved de maksimalt anbefalede doser.
During in vitro studies, cloned human cardiac potassium channels (HERG) were inhibited by 30% at the highest concentrations of lopinavir/ritonavir tested, corresponding to a lopinavir exposure 7-fold total and 15-fold free peak plasma levels achieved in humans at the maximum recommended therapeutic dose.
I in vitro undersøgelser hæmmede ospemifen og 4-hydroxyospemifen ikke P-glycoprotein (P-gp), brystcancerresistent protein (BCRP), organisk aniontransportørpolypeptid (OATP)1B1, OATP1B3, OCT2, organisk aniontransportør (OAT)1 eller OAT3 ved klinisk relevante koncentrationer.
In in vitro studies, ospemifene and 4-hydroxyospemifene did not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT2, organic anion transporter (OAT)1 or OAT3 at clinically relevant concentrations.
I in vitro-analysen med muselymfomer var eltrombopag marginalt positivt (< 3 gange forøget mutationshyppighed).
In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (< 3-fold increase in mutation frequency).
I in vitro-studier hæmmer bosutinib proliferationen og overlevelsen af etablerede CML-cellelinjer, Ph+ akut lymfoblastisk leukæmi-cellelinjer og patientderiverede primære primitive CML-celler.
In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ acute lymphoblastic leukaemia cell lines, and patient-derived primary primitive CML cells.
I in vitro-studier konkurrerede perampanel ikke med AMPA for binding til AMPA-receptoren, men perampanel-bindingen blev fortrængt af nonkompetitive AMPA-receptorantagonister, hvilket indikerer, at perampanel er en nonkompetitiv AMPA-receptorantagonist.
In in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that perampanel is a noncompetitive AMPA receptor antagonist.
I in vitro-studier udvirkede canagliflozin hverken hæmning af cytokrom P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6 og CYP2E1, CYP2B6, CYP2C8 og CYP2C9 eller induktion af CYP1A2,
In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2,CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6,
I in vitro-studier var IC50-værdierne for serotonin-transportør- og KATP-kanaler 7 respektive 12 gange højere end EC50 for calciumreceptoren ved samme forsøgsbetingelser.
In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12 fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
I in vitro-studier viste visse antibiotika (doxycyclin, cefdinir), antikonvulsiva (valproatnatrium), antidepressiva (sertralin HCl), bisphosphonat (alendronatnatrium), antiparkinson-midler (levodopa) og immunosuppressanter (methotrexat), at de potentielt kan interagere med Fexeric: ethvert af disse eller andre lægemidler, som potentielt kan interagere med Fexeric, skal tages mindst 2 timer før eller efter Fexeric.
From in vitro studies, certain antibiotic (doxycycline, cefdinir), anticonvulsant (valproate sodium), antidepressant (sertraline HCl), bisphosphonate (alendronate sodium), anti-parkinsonian (levodopa) and immunosuppressant (methotrexate) medications showed the potential to interact with Fexeric: any of these or other medicinal products that have the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
I in vitro-undersøgelser af bl.a. binding til insulin- og IGF-1-receptorsteder samt virkning på cellevækst opførte insulin aspart sig meget lig humaninsulin.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
I Indberetning af bivirkninger
Reporting of side effects
I indberetninger efter markedsføring er det observeret, at IVIG-højdosisindikationer hos børn, især med Kawasakis sygdom, er forbundet med en øget indberetning af hæmolytiske reaktioner sammenlignet med andre IVIG-indikationer hos børn.
In postmarketing reports it is observed that IVIG high-dose indications in children, particularly Kawasaki disease, are associated with an increased reporting rate of haemolytic reactions compared to other IVIG indications in children.
I individuelle tilfælde af atrofisk gastritis kan udåndingsprøven give et falsk positivt resultat, og det kan være nødvendigt at anvende andre prøver for at bekræfte tilstedeværelsen af H. pylori.
In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of H. pylori.
I indlægssedlen er der yderligere anvisninger om, hvordan inhalatoren skal bruges.
For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.
I induktionsstudier med Crohns sygdom blev der ikke rapporteret om anafylaktiske hændelser eller andre alvorlige infusionsrelaterede bivirkninger efter en enkelt intravenøs dosis.
In Crohn’s disease induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose.
I infliximab-gruppen forblev middelæ ndringen i samlet modificeret vdH-S score under 0 i uge 54.
In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
I ingen af de to studier var anvendelse af spironolacton tilladt, eftersom spironolacton binder til androgenreceptoren og kan øge PSA-koncentrationen.
In both studies spironolactone use was not allowed as spironolactone binds to the androgen receptor and may increase PSA levels.
I initiale studier med raske forsøgspersoner blev administration af en enkelt dosis posaconazol indgivet over 30 minutter via et perifert venekateter associeret med en forekomst af reaktioner på infusionsstedet på 12 % (forekomst af tromboflebitis på 4 %).
In initial studies of healthy volunteers, administration of a single dose of posaconazole infused over 30 minutes via a peripheral venous catheter was associated with a 12 % incidence of infusion site reactions (4 % incidence of thrombophlebitis).
I INOT27-forsøget blev 795 for tidligt fødte børn (GA<29 uger) med hypoxisk respirationssvigt randomiseret til at få enten INOmax (n=395) i en dosis på 5 ppm eller nitrogen (placebo n=400) med start inden for de første 24 timer efter fødslen og behandlet i mindst 7 dage og op til 21 dage.
In the INOT27 trial, 795 preterm infants (GA<29 weeks) with hypoxic respiratory failure were randomised to receive either INOmax (n=395) in a dose of 5 ppm or nitrogen (placebo n=400), beginning within the first 24 hours of life and treated for at least 7 days, up to 21 days.
I INPULSIS-2 havde patienterne, der fik placebo, en større stigning i den samlede SGRQ-score fra baseline sammenlignet med patienter, der fik nintedanib 150 mg to gange daglig.
In INPULSIS-2, patients receiving placebo had a larger increase from baseline SGRQ total score as compared to patients receiving nintedanib 150 mg twice daily.
I INPULSIS-2-studiet var risikoen for den første akutte IPF-eksacerbation i løbet af 52 uger signifikant reduceret hos patienter, der fik nintedanib, sammenlignet med placebo; i INPULSIS-1- studiet var der ingen forskel mellem behandlingsgrupperne.
In the INPULSIS-2 trial, the risk of first acute IPF exacerbation over 52 weeks was significantly reduced in patients receiving nintedanib compared to placebo, in the INPULSIS-1 trial there was no difference between the treatment groups.
I INPULSIS-studierne blev en patient utilsigtet eksponeret over for en dosis på 600 mg dagligt i 21 dage i alt.
In the INPULSIS trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days.
I insulin glulisin faciliterer udskiftningen af den humane insulinaminosyre asparagin i position B3 med lysin og af lysin i position B29 med glutaminsyre en hurtigere absorption.
In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favors more rapid absorption.
I insulininfusionspumper.
In insulin infusion pumps.
I intent-to-treat analyser opnåede 72 % og 36 % af patienterne reduktion i plasma hiv-1 RNA på < 400 kopier/ml i henholdsvis uge 16 og 104.
In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of  400 copies/ml at Week 16 and 104, respectively.
I intent-to-treat- populationen (ITT-populationen) fik 258 patienter isavuconazol, og 258 patienter fik voriconazol.
In the intent-to-treat (ITT) population, 258 patients received isavuconazole and 258 patients received voriconazole.
I intent-to-treat-analysen var forekomsten af komplet remission på 23,6 % (95 % CI: 13,2, 37) hos 13/55 forsøgspersoner, der fik Dacogen.
In the intent-to-treat analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
I intent-to-treat-populationen (alle randomiserede) var medianalderen 63 år (31-87 år), 57 % var mænd, 61 % var hvide, og 33 % var asiater.
In the intent to treat (all randomised) population, the median age was 63 years (range 31-87 years), 57 % were males, and 61% were White and 33% were Asian.
I interaktionsforsøg påvirkede lacosamid ikke signifikant plasmakoncentrationen af carbamazepin og valproinsyre.
In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
I interaktionsstudier af raske frivillige havde sevelamer hydrochlorid, der indeholder samme aktive fragment som sevelamer carbonat, ingen virkning på biotilgængeligheden af digoxin, warfarin, enalapril eller metoprolol.
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
I interaktionsstudier af raske frivillige havde sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, ingen virkning på biotilgængeligheden af digoxin, warfarin, enalapril eller metoprolol.
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
I intramuskulære flerdosis toksicitetsstudier med rotter og hunde var den antiøstrogene aktivitet af fulvestrant årsag til de fleste observerede virkninger, specielt i hunkønnenes reproduktionssystem, men også i andre organer, som hos begge køn er følsomme overfor hormoner.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the anti- estrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
I intravenøse bolusstudier faldt dosis, som var fint tolereret med stigende studievarighed: 0,2 og 0,02 mg/kg dagligt var fint tolereret i 4 uger hos henholdsvis rotter og hunde, men kun 0,01 mg/kg og 0,005 mg/kg hos henholdsvis rotter og hunde, når det indgives i 52 uger.
In the intravenous bolus studies, the doses that were well- tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
I intravenøse infusionsstudier blev renal tolerabilitet overfor zoledronsyre bestemt hos rotter, som fik 0,6 mg/kg givet som 15 minutters infusion i alt seks gange med 3 dages interval (for en kumulativ dosis svarende til AUC niveau cirka 6 gange højere den humane terapeutiske eksponering), mens fem 15 minutters infusioner af 0,25 mg/kg blev administreret med 2–3 ugers interval (en kumulativ dosis svarende til 7 gange den humane terapeutiske eksponering) hos hunde var fint tolereret.
0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2–3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
I intravenøse infusionsstudier blev renal tolerabilitet overfor zoledronsyre bestemt hos rotter, som fik 0,6 mg/kg givet som 15 minutters infusion i alt seks gange med 3 dages interval (for en kumulativ dosis svarende til AUC niveau cirka 6 gange højere den humane terapeutiske eksponering), mens fem 15 minutters infusioner af 0,25 mg/kg blev administreret med 2–3 ugers interval (en kumulativ dosis svarende til 7 gange den humane terapeutiske eksponering) hos hunde var fint tolereret.
In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.