natgillin/translations-raw huggingface dataset:
I enoxaparin/VKA-gruppen var der ingen klar sammenhæng mellem niveauet for middel-center-TTR på centerniveau (Time in Target INR Range på 2,0-3,0) i de lige store tertiler og forekomsten af recidiverende VTE (p = 0,032 for interaktion).
In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 – 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (P=0.932 for interaction).
I ESPRIT blev blødningshændelser rapporteret ved 48 timer og ikke- blødningshændelser ved 30 dage.
In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days.
i está tomando otros medicamentos mielosupresores (que reducen la producción de glóbulos rojos o blancos o de plaquetas) o si recibe radioterapia; si tiene carencia conocida de vitamina B12 o de folato.
if you are taking other myelosuppressive medicines (decrease production of red, white, or coagulating blood cells) or receiving radiation therapy, if you have a known lack of vitamin B12 or folate.
I et 1 års studie viste konjugeret østrogen 0,45 mg/bazedoxefin 20 mg en signifikant forskel fra baseline for BMD af columna lumbalis (+1,52 %) ved 12. måned sammenlignet med placebo.
In a 1 year study, CE 0.45 mg/bazedoxifene 20 mg showed a significant difference from baseline in lumbar spine BMD (+1.52%) at Month 12 compared to placebo.
I et 1-måneds oralt gavagestudie (tvangsfodring) til fastlæggelse af dosisinterval (0, 10, 25, 75 og 200 mg/kg/dag), med fortløbende daglig dosering hos rasH2 transgene mus, blev der set karcinom og Brunnerkirtel hyperplasi i duodenum ved den højeste testdosis (200 mg/kg/dag).
In a 1-month, oral gavage dose-range finding study (0, 10, 25, 75, or 200 mg/kg/day) with continuous daily dosing in rasH2 transgenic mice, carcinoma and hyperplasia of Brunner’s glands of the duodenum were observed at the highest dose (200 mg/kg/day) tested.
I et 1-årigt studie hos patienter med ikke-transfusionsafhængige thalassæmi-syndromer og jernophobning (dispergible tabletter med en dosis på 10 mg/kg/day) var diarré (9,1%), udslæt (9,1%) og kvalme (7,3%) de hyppigste bivirkninger ved forsøgslægemidlet.
In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea (7.3%) were the most frequent study drug-related adverse events.
I et 1-årigt toksicitetsforsøg med cynomolgus-aber var abatacept ikke forbundet med signifikant toksicitet.
In a one-year toxicity study in cynomolgus monkeys, abatacept was not associated with any significant toxicity.
I et 104 ugers klinisk studie opnåede 57% af de patienter med type 2-diabetes, der blev behandlet med insulin degludec i kombination med metfomin, et target HbA1c på <7%, og de resterende patienter fortsatte i et 26 ugers åbent studie og blev randomiseret til at tilføje liraglutid eller en enkelt dosis insulin aspart (i forbindelse med hovedmåltidet).
In a 104­week clinical trial, 57% of patients with type 2 diabetes treated with insulin degludec in combination with metformin achieved a target HbA1c <7% and the remaining patients continued in a 26­week open label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
I et 104 ugers klinisk studie opnåede 57% af de patienter med type 2-diabetes, der blev behandlet med Tresiba (insulin degludec) i kombination med metfomin, et target HbA1c på <7,0%, og de resterende patienter fortsatte i et 26 ugers åbent studie og var randomiserede til at tilføje liraglutid eller en enkelt dosis insulin aspart (i forbindelse med hovedmåltidet).
In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with Tresiba (insulin degludec) in combination with metformin achieved a target HbA1c < 7.0% and the remaining patients continued in a 26-week open label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
I et 104-ugers karcinogenicitetsstudie med depotformulering af exenatid blev der observeret en statistisk signifikant stigning i forekomsten af thyroide C-celletumorer (adenomer og/eller karcinomer) hos rotter ved alle doser (1,4 til 26 gange den humane kliniske eksponering med depotformulering af exenatid).
In a 104-week carcinogenicity study with prolonged-release exenatide a statistically significant increase in thyroid C-cell tumour incidence (adenomas and / or carcinomas) was observed in rats at all doses (1.4- to 26- fold the human clinical exposure with prolonged-release exenatide).
I et 104-ugers karcinogenicitetsstudie med depotformulering af exenatid blev der observeret en statistisk signifikant stigning i forekomsten af thyroide C-celletumorer (adenomer og/eller karcinomer) hos rotter ved alle doser (1,4 til 26 gange den humane kliniske eksponering med depotformulering af exenatid).
In a 104-week carcinogenicity study with prolonged-release exenatide a statistically significant increase in thyroid C-cell tumour incidence (adenomas and / or carcinomas) was observed in rats at all doses (1.4- to 26-fold the human clinical exposure with prolonged-release exenatide).
I et 12- ugers klinisk studie steg ustimuleret LH ikke hos mandlige patienter, der blev behandlet med canagliflozin.
In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
I et 12- ugers studie reducerede konjugeret østrogen 0,45 mg/bazedoxifen 20 mg signifikant både antallet og sværhedsgraden af hedeture i forhold til placebo ved uge 4 og 12.
In a 12-week study, CE 0.45 mg/bazedoxifene 20 mg significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12.
I et 13 ugers-forsøg (n = 636), der sammenlignede tre faste doser af Xeplion (indledende injektion på 150 mg i musculus deltoideus, efterfulgt af 3 gluteal- eller deltadoser på enten 25 mg/4 uger,
In a 13-week study (n=636) comparing three fixed doses of Xeplion (initial deltoid injection of 150 mg followed by 3 gluteal or deltoid doses of either 25 mg/4 weeks, 100 mg/4 weeks or
I et 144-ugers klinisk studie, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz til antiretroviral-naive patienter, blev der observeret små fald i knoglemineraltætheden i hofte og rygsøjle i begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
I et 144-ugers kontrolleret klinisk studie, hvor tenofovirdisoproxilfumarat blev sammenlignet med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, blev der observeret små fald i knoglemineraltætheden (bone mineral density, BMD) i hoften og i rygsøjlen i begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
I et 144-ugers kontrolleret, klinisk studie med hiv-inficerede patienter, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral- naive voksne patienter, sås små reduktioner i knoglemineraltætheden (BMD) i hoften og rygraden hos begge behandlingsgrupper.
In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve adult patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
I et 144-ugers kontrolleret, klinisk studie, hvor tenofovirdisoproxill blev sammenlignet med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, blev der observeret små fald i knoglemineraltætheden (bone mineral density, BMD) i hoften og i rygsøjlen i begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
I et 144-ugers kontrolleret, klinisk studie, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, sås mindre reduktioner i BMD i hoften og rygraden hos begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
I et 144-ugers kontrolleret, klinisk studie, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral-naive patienter, sås små reduktioner i BMD i hoften og rygraden hos begge behandlingsgrupper.
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
I et 18-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin som monoterapi desuden undersøgt hos patienter, som ikke var egnede til behandling med metformin på grund af intolerans eller kontraindikation på grund af nedsat nyrefunktion.
The efficacy and safety of linagliptin monotherapy was also evaluated in patients for whom metformin therapy is inappropriate, due to intolerability or contraindicated due to renal impairment, in a double- blind placebo-controlled study of 18 weeks duration.
I et 2 år langt karcinogenicitetsforsøg med hunmus forårsagede ospemifen behandlingsrelaterede stigninger i neoplastiske fund i binyrerne og ovarie.
In a 2-year carcinogenicity study in female mice, ospemifene caused treatment related increases in neoplastic findings in the adrenal gland and ovary.
I et 2 år langt karcinogenicitetsforsøg med rotter blev der registreret en klar øgning i hovedsageligt benigne tumorer i thymus ved alle dosisniveauer af ospemifen.
In a 2-year carcinogenicity study in rats, a clear increase in mostly benign thymic tumours was recorded at all ospemifene dose levels.
I et 2-årigt forsøg af karcinogenicitet, hvor bazedoxifen blev administreret oralt i maden til rotter i doser på 0%, 0,003 %, 0,01 %, 0,03 % eller 0,1 %, sås eksponeringer på henholdsvis 0,05-4 hos hanner og 0,26-6,61 hos hunner.
In the 2-year carcinogenicity study, bazedoxifene, administered orally in the diet to rats at dosages of 0%, 0.003%, 0.01%, 0.03%, or 0.1%, resulted in exposure ratios of 0.05 to 4 in males and
I et 2-årigt studie til evaluering af icabitants kræftfremkaldende potentiale hos rotter havde daglige doser i eksponeringsniveauer på det dobbelte af det, der opnås efter terapeutiske doser hos mennesker, ingen effekt på forekomsten eller morfologien af tumorer.
In a 2 year study to evaluate the carcinogenic potential of icatibant in rats, daily doses giving exposure levels up to approximately 2-fold that achieved after a therapeutic dose in humans had no effect on the incidence or morphology of tumours.
I et 2-årigt toksicitetsforsøg er der set øget nonadrenal thrombose hos han-rotter ved høje doser.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
I et 2-års karcinogenicitetsstudier i rotter (0, 0,33, 1, eller 3 mg/kg/dag) resulterede administration af sunitinib i cykli på 28 dage efterfulgt af en 7-dages doseringsfri periode i en øgning af fæokromocytom og binyremarvhyperplasi hos hanrotter, der fik 3 mg/kg/dag efter > 1 års dosering
In a 2-year rat carcinogenicity study (0, 0.33, 1, or 3 mg/kg/day), administration of sunitinib in 28-day cycles followed by 7-day dose-free periods resulted in increases in the incidence of pheochromocytomas and hyperplasia in the adrenal medulla of male rats given 3 mg/kg/day following
I et 2-års, randomiseret, dobbeltblindet, non-inferiority, multicenterstudie (BM 16550) var intravenøs injektion af Bondenza 3 mg hver 3. måned mindst ligeså effektivt som oral ibandronsyre 2,5 mg daglig hos postmenopausale kvinder (1.386 kvinder i alderen 55-80 år) med osteoporose (lumbal BMD T-score under – 2,5 SD ved baseline).
Bondenza 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, non- inferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
I et 2-års, randomiseret, dobbeltblindet, non-inferiority, multicenterstudie (BM 16550) var intravenøs injektion af Bonviva 3 mg hver 3. måned mindst ligeså effektivt som oral ibandronsyre 2,5 mg daglig hos postmenopausale kvinder (1.386 kvinder i alderen 55-80 år) med osteoporose (lumbal BMD T- score under – 2,5 SD ved baseline).
Bonviva 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, non- inferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
I et 2-års, randomiseret, dobbeltblindet, non-inferiority, multicenterstudie (BM 16550) var intravenøs injektion af ibandronsyre 3mg hver 3. måned mindst ligeså effektivt som oral ibandronsyre 2,5 mg daglig hos postmenopausale kvinder (1.386 kvinder i alderen 55-80 år) med osteoporose (lumbal BMD T-score under – 2,5SD ved baseline).
Ibandronic acid 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, non- inferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
I et 24- måneders karcinogenicitetsstudie hos rotter øgede abirateronacetat incidensen af interstitialcelletumorer i testiklerne.
In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
I et 24-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin, som monoterapi, undersøgt.
The efficacy and safety of linagliptin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
I et 24-ugers placebokontrolleret studie blev effekten og sikkerheden af linagliptin 5 mg undersøgt hos patienter, der ikke var tilstrækkeligt behandlet med en kombination af metformin og et sulfonylurinstof.
A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea.
I et 24-ugers placebokontrolleret studie blev virkningen og sikkerheden af linagliptin 5 mg undersøgt hos patienter, der ikke var tilstrækkeligt behandlet med en kombination af metformin og et sulfonylurinstof.
A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea.
I et 24-ugers placebokontrolleret, faktorielt studie af initialbehandling gav linagliptin 2,5 mg 2 gange dagligt i kombination med metformin (500 mg eller 1.000 mg 2 gange dagligt) en signifikant forbedring af glykæmiske parametre sammenlignet med begge former for monoterapi, jf. tabel 5 (gennemsnitligt baseline-HbA1c 8,65 %).
In a 24-week placebo-controlled factorial study of initial therapy, linagliptin 2.5 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycemic parameters compared with either monotherapy as summarised in Table 5 (mean baseline HbA1c 8.65%).
I et 24-ugers studie (HZA113091) med voksne og unge patienter med persisterende astma blev der påvist forbedringer i lungefunktionen i forhold til baseline med både fluticasonfuroat/vilanterol 92/22 mikrogram indgivet en gang daglig om aftenen og salmeterol/FP 50/250 mikrogram indgivet to gange daglig.
In a 24 week study (HZA113091) in adult and adolescent patients with persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
I et 26 ugers fase III klinisk studie med sammenligning af insulin glulisin og insulin lispro, begge injiceret subkutant kort tid (0-15 minutter) før et måltid, til patienter med type 1 diabetes mellitus som brugte insulin glargin som basal insulin, kunne insulin glulisin sidestilles med insulin lispro med hensyn til glykæmisk kontrol afspejlet ved ændringer i glykosyleret hæmoglobin (udtrykt som HbA1c ækvivalent) fra baseline til endepunktet.
In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint.
I et 26 ugers fase III klinisk studie med sammenligning af insulin glulisin og insulin lispro, begge injiceret subkutant kort tid (0-15 minutter) før et måltid, til patienter med type 1 diabetes mellitus, som brugte insulin glargin som basal insulin, kunne insulin glulisin sidestilles med insulin lispro med hensyn til glykæmisk kontrol afspejlet ved ændringer i glykosyleret hæmoglobin (udtrykt som HbA1c ækvivalent) fra baseline til endepunktet.
In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint.
I et 26 ugers klinisk studie havde patienter med type 2-diabetes og moderat nedsat nyrefunktion (CrCL 30-59 ml/min) tilsvarende 26% lavere eksponering for liraglutid, sammenlignet med type 2-diabetes- patienter med normal nyrefunktion eller mild nedsat nyrefunktion i et separat studie.
Similarly, in a 26-week clinical trial, patients with type 2 diabetes and moderate renal impairment (CrCL 30-59 mL/min) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
I et 26-ugers dobbeltblindt studie blev depotformulering af exenatid sammenlignet med sitagliptin og pioglitazon i maksimumdoser hos forsøgsdeltagere, der også fik metformin.
In a 26-week double-blind study prolonged-release exenatide was compared to maximum daily doses of sitagliptin and pioglitazone in subjects also using metformin.
I et 26-ugers studie, der sammenligner Ultibro Breezhaler (n=258) og fluticason/salmeterol (n=264), var antallet af moderate til svære KOL-eksacerbationer/patient-år henholdsvis 0,15 versus 0,18 (18 tilfælde versus 22 tilfælde) (p=0,512), og antallet af alle KOL-eksacerbationer/patient-år (milde, moderate og svære) var henholdsvis 0,72 versus 0,94 (86 tilfælde versus 113 tilfælde) (p=0,098).
In a 26-week study comparing Ultibro Breezhaler (n=258) and fluticasone/salmeterol (n=264), the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
I et 26-ugers studie, der sammenligner Ulunar Breezhaler (n=258) og fluticason/salmeterol (n=264), var antallet af moderate til svære KOL-eksacerbationer/patient-år henholdsvis 0,15 versus 0,18 (18 tilfælde versus 22 tilfælde) (p=0,512), og antallet af alle KOL-eksacerbationer/patient-år (milde, moderate og svære) var henholdsvis 0,72 versus 0,94 (86 tilfælde versus 113 tilfælde) (p=0,098).
In a 26-week study comparing Ulunar Breezhaler (n=258) and fluticasone/salmeterol (n=264), the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
I et 26-ugers studie, der sammenligner Xoterna Breezhaler (n=258) og fluticason/salmeterol (n=264), var antallet af moderate til svære KOL-eksacerbationer/patient-år henholdsvis 0,15 versus 0,18 (18 tilfælde versus 22 tilfælde) (p=0,512), og antallet af alle KOL-eksacerbationer/patient-år (milde, moderate og svære) var henholdsvis 0,72 versus 0,94 (86 tilfælde versus 113 tilfælde) (p=0,098).
In a 26-week study comparing Xoterna Breezhaler (n=258) and fluticasone/salmeterol (n=264), the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patient-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
I et 26-ugers, kontrolleret, dobbeltblindt, multinationalt forsøg med olanzapin til behandling af skizofreni, som inkluderede 314 voksne patienter, og hvor det primære endepunkt var vægtstigning, fandtes signifikant færre patienter at have 7 % eller yderligere vægtstigning i forhold til baseline (dvs en stigning på mindst 5,6 kg for en middel-baselinevægt på ~80,5 kg) med aripripazol (n=18 eller 13 % af de evaluérbare patienter) sammenlignet med olanzapin (n=45 eller 33 % af de evaluérbare patienter).
In a 26- week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (n= 18, or 13% of evaluable patients), compared to olanzapine (n= 45, or 33% of evaluable patients).
I et 26-ugers, placebokontrolleret forsøg med voksne stabiliserede patienter med kronisk skizofreni var Aripiprazole forbundet med en signifikant større reduktion i tilbagefaldsraten; 34 % i Aripiprazole gruppen og 57 % i placebo.
In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% in placebo.
I et 26-ugers, placebokontrolleret forsøg, efterfulgt af en 74-ugers forlængelse, med maniske patienter, som oplevede remission med aripiprazol under en stabiliseringsfase inden randomisering, havde aripiprazol bedre effekt end placebo ved forebyggelse af bipolært recidiv, primært ved at forebygge recidiv af mani, men havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.