natgillin/translations-raw huggingface dataset:
Et randomiseret og dobbeltblindt studie undersøgte abatacept s.c. i kombination med methotrexat (abatacept + MTX), abatacept s.c.-monoterapi eller methotrexat-monoterapi (MTX-gruppe) med hensyn til induktion af remission efter 12 måneders behandling, samt opretholdelse af lægemiddelfri remission efter seponering af alle lægemidlerhos MTX-naive voksne patienter med højaktiv, tidlig reumatoid artritis med faktorer, der indikerer en dårlig prognose.
A randomized and double-blinded study evaluated abatacept SC in combination with methotrexate (abatacept + MTX), abatacept SC monotherapy, or methotrexate monotherapy (MTX group) in induction of remission following 12 months of treatment, and maintenance of drug-free remission after complete drug withdrawal in MTX-naive adult patients with highly active early rheumatoid arthritis with poor prognostic factors.
Et randomiseret og kontrolleret klinisk studie (EGF114299) med en patientpopulation, der overordnet er identisk med den fra EGF30008, bortset fra, at patienterne forinden skal have fået behandling med trastuzumab med aromatase-hæmmer + trastuzumab er inkluderet som reference-arm.
A randomised and controlled clinical trial (EGF114299) in a patient population essentially identical to that of EGF30008 except that subjects must have received prior treatment with trastuzumab, with aromatase inhibitor (AI) + trastuzumab included as the reference arm.
Et randomiseret studie undersøgte den kliniske responsrate hos DMARD-naïve patienter med tidlig reumatoid artrit (n = 121), som i to parallelle grupper enten fik 20 mg eller 100 mg leflunomid i den indledende tre dage lange dobbeltblinde periode.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n = 121) with early RA, who received either 20 mg or 100 mg of leflunomide with matching placebo in two parallel groups during the init ial threeday double blind period.
Et randomiseret studie undersøgte den kliniske responsrate hos DMARD-naïve patienter med tidlig reumatoid artrit (n=121), som i tp parallelle grupper enten fik 20 mg eller 100 mg leflunomid i den indledende tre dage lange dobbeltblinde periode.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Et randomiseret, blindet fase III-multicenterstudie blev udført for at vurdere sikkerhed og virkning af pasireotid til intramuskulær anvendelse versus octreotid til intramuskulær anvendelse hos behandlingsnaive patienter med aktiv akromegali.
A phase III multicentre, randomised, blinded study was conducted to assess the safety and efficacy of pasireotide intramuscular use versus octreotide intramuscular use in medically naïve patients with active acromegaly.
Et randomiseret, dobbeltblindet cross-over PK/PD studie, som sammenlignede insulin aspart med opløseligt humaninsulin, blev udført med ældre patienter med type 2-diabetes (19 patienter mellem 65- 83 år, gennemsnitsalder 70 år).
A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years).
Et randomiseret, dobbeltblindet morbiditets-mortalitets studie kaldet ”Antihypertensive and Lipid- Lowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calciumantagonist) eller lisinopril 10-40 mg/dag (ACE- hæmmer) som førstevalgsbehandling i stedet for et thiaziddiuretikum, chlorthalidon 12,5-25 mg/dag ved let til moderat hypertension.
A randomised double-blind morbidity-mortality study called the Antihypertensive and Lipid- Lowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACE- inhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.
Et randomiseret, dobbeltblindet morbiditets-mortalitets studie kaldet ”Antihypertensive and Lipid- Lowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calciumantagonist) eller lisinopril 10-40 mg/dag (ACE- hæmmer) som førstevalgsbehandling i stedet for et thiaziddiuretikum, chlorthalidon 12,5-25 mg/dag ved let til moderat hypertension.
A randomised double-blind morbidity-mortality study called the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACE-inhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.
Et randomiseret, dobbeltblindet, aktivt kontrolleret multicenter-, noninferioritetsstudie blev udført for at vurdere immunogeniciteten for Fluenz Tetra sammenlignet med Fluenz (aktiv kontrol) hos børn og unge i alderen 2-17 år.
A multicenter, randomised, double-blind, active-controlled, non-inferiority study was conducted to assess the immunogenicity of Fluenz Tetra compared to Fluenz (active control) in children and adolescents 2-17 years of age.
Et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie undersøgte den hepatiske sikkerhed af maraviroc i kombination med andre antiretrovirale lægemidler hos HIV-1-smittede forsøgspersoner med HIV RNA <50 kopier/ml og samtidig hepatitis C- og/eller hepatitis B- virusinfektion.
The hepatic safety of maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects with HIV RNA <50 copies/mL, co-infected with Hepatitis C and/or Hepatitis B Virus was evaluated in a multicentre, randomized, double blinded, placebo-controlled study.
Et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie undersøgte den hepatiske sikkerhed af maraviroc i kombination med andre antiretrovirale lægemidler hos HIV-1-smittede forsøgspersoner med HIV-RNA <50 kopier/ml og samtidig hepatitis C- og/eller hepatitis B- virusinfektion.
The hepatic safety of maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects with HIV RNA <50 copies/mL, co-infected with Hepatitis C and/or Hepatitis B Virus was evaluated in a multicentre, randomized, double blinded, placebo-controlled study.
Et randomiseret, dobbeltblindt, aktivt kontrolleret non-inferioritetsstudie (studie 1) sammenlignede ækvivalente doser af glycerolphenylbutyrat og natriumphenylbutyrat ved at evaluere det venøse ammoniakniveau i 24 timer hos patienter med UCD'er, som var blevet behandlet med natriumphenylbutyrat inden inklusion med henblik på regulering af deres UCD.
A randomised, double-blind, active-controlled, crossover, noninferiority study (Study 1) compared equivalent doses of glycerol phenylbutyrate to sodium phenylbutyrate by evaluating 24-hour venous ammonia levels in patients with UCDs who had been on sodium phenylbutyrate prior to enrolment for control of their UCD.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide BMS som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of Irbesartan Hydrochlorothiazide BMS as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active- controlled, 8-week, parallel-arm study.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide Zentiva som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of Irbesartan Hydrochlorothiazide Zentiva as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af irbesartan/hydrochlorthiazid som initial behandling ved svær hypertension (defineret som SeDBT ≥ 110 mm Hg).
Efficacy and safety of irbesartan/hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP  110 mmHg) was evaluated in a multicenter, randomised, double-blind, active-controlled, 8-week, parallel-arm study.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret virkningen og sikkerheden af kombinationen irbesartan og hydrochlorthiazid som initial behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of the combination of irbesartan and hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (JMEN) sammenlignede virkning og sikkerhed af vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC) (n = 441) med placebo plus BSC (n = 222) hos patienter med lokalt fremskreden (trin IIIB) eller metastatisk (trin IV) ikke-småcellet lungecancer (NSCLC), som ikke fik bedring efter 4 serier med 1. linje-dubletbehandling bestående af cisplatin eller carboplatin sammen med gemcitabin, paclitaxel eller docetaxel.
A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (N = 441) with that of placebo plus BSC (N = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non- Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first-line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Et randomiseret, evaluator-blindet, kontrolleret studie hos hiv-inficerede patienter med azol-følsom oropharyngeal candidiasis blev afsluttet (de fleste undersøgte patienter havde C. Albicans isoleret ved baseline).
A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azole- susceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Et randomiseret, open-label placebo-studie blev foretaget hos børn og unge med astma (i alderen 6-17 år), voksne med astma (i alderen 18-45 år) og raske frivillige (i alderen 18-45 år) for at vurdere den maksimale inspiratoriske flow (PIF) hastighed og andre relaterede inhalationsparametre efter inhalation fra et Spiromax-device (indeholdende placebo) sammenlignet med inhalation fra en allerede markedsført tørpulverinhalator (indeholdende placebo) med flere doser.
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years)and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Et randomiseret, open-label placebo-studie blev foretaget hos børn og unge med astma (i alderen 6-17 år), voksne med astma (i alderen 18-45 år), voksne med kronisk obstruktiv lungesygdom (KOL – i alderen > 50 år) og raske frivillige (i alderen 18-45 år) for at vurdere den maksimale inspiratoriske flow (PIF) hastighed og andre relaterede inhalationsparametre efter inhalation fra et Spiromax-device (indeholdende placebo) sammenlignet med inhalation fra en allerede markedsført tørpulverinhalator (indeholdende placebo) med flere doser.
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD – aged >50 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Et randomiseret, open-label placebo-studie blev foretaget hos børn og unge med astma (i alderen 6-17 år), voksne med astma (i alderen 18-45 år), voksne med kronisk obstruktiv lungesygdom (KOL – i alderen > 50 år) og raske frivillige (i alderen 18-45 år) for at vurdere den maksimale inspiratoriske flow (PIF) hastighed og andre relaterede inhalationsparametre efter inhalation fra et Spiromax-device (indeholdende placebo) sammenlignet med inhalation fra en allerede markedsført tørpulverinhalator (indeholdende placebo) med flere doser.
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD – aged >50 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device(containing placebo).
Et randomiseret, open-label placebostudie blev foretaget hos børn og unge med astma (i alderen 6-17 år), voksne med astma (i alderen 18-45 år), voksne med kronisk obstruktiv lungesygdom (KOL – i alderen > 50 år) og raske frivillige (i alderen 18-45 år) for at vurdere den maksimale inspiratoriske flow (PIF) hastighed og andre relaterede inhalationsparametre efter inhalation fra et Spiromax-device (indeholdende placebo) sammenlignet med inhalation fra en allerede markedsført tørpulverinhalator (indeholdende placebo) med flere doser.
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD – aged >50 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Et randomiseret, åbent, aktivt kontrolleret fase 3-studie (RESPONSE) er gennemført med 222 patienter med PV, som var refraktære over for eller ikke tålte hydroxycarbamid, defineret ved Europæisk Leukæmi Nets (ELN) internationale arbejdsgruppes publicerede kriterier.
A randomised, open-label, active-controlled phase 3 study (RESPONSE) was conducted in 222 patients with PV who were resistant to or intolerant of hydroxyurea defined based on the
Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin mod gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent-To- Treat [ITT] population n=865) mødte dets primære endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84- 1,05).
A multi-centre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population N = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT N = 863) in overall survival (adjusted hazard ratio (HR) 0.94; 95% CI= 0.84-1.05).
Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin mod gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=865) mødte dets første endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84-1,05).
A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95 % CI = 0.84 - 1.05).
Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin versus gemcitabin plus cisplatin til patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (stadie IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent- To-Treat (ITT) population n=865) mødte dets primære endepunkt og viste tilsvarende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84-1,05).
A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI = 0.84-1.05).
Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin versus gemcitabin plus cisplatin til patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (stadie IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent- To-Treat (ITT) population n=865) mødte dets primære endepunkt og viste tilsvarende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84–1,05).
A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI = 0.84-1.05).
Et ravfarvet hætteglas med Cayston med eller uden et blåt låg.
One amber-coloured vial of Cayston with or without a blue cap.
Et realistisk mål for dit vægttab vil være 5-10 % af din startvægt.
A realistic goal is to lose between 5 % to 10 % of your starting weight.
Et reproduktionsstudie med cynomolgusaber viste ingen tegn på embryoføtal toksicitet eller teratogen virkning, men medførte fuldstændig depletering af B-lymfocytter hos afkommet.
A reproduction study in cynomolgus monkeys showed no evidence of embryofoetal toxicity or teratogenic effects but resulted in a complete depletion of B lymphocytes in offspring.
Et retrospektivt europæisk forsøg, som vurderede brugen af G-CSF efter allogen knoglemarvstransplantation hos patienter med akut leukæmi, tydede på en øget risiko for GvHD, behandlingsrelateret mortalitet (TRM) og mortalitet, når G-CSF blev administreret.
One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Et retrospektivt europæisk studie om brugen af G-CSF efter allogen knoglemarvstransplantation til patienter med akutte leukæmier tydede på en øget risiko for GvHD, behandlingsrelateret mortalitet (BRM) og mortalitet efter indgift af G-CSF.
One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Et retrospektivt kohorte-observationsstudie af ospemifen til vurdering af incidensen af venøs tromboemboli og andre sikkerhedsmæssige spørgsmål, som er godkendt i risikostyringsplanen, hos VVA-patienter, der er behandlet med ospemifen, sammenlignet med 1) patienter, der for nyligt har fået ordineret SERM’er mod østrogenmangeltilstande eller til forebyggelse af brystcancer, og 2) incidensen hos
An observational retrospective cohort study of ospemifene to assess the incidence of venous thromboembolism and other safety concerns as agreed in the risk management plan, in VVA patients treated with ospemifene compared to 1) patients newly prescribed SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the incidence in untreated VVA patients.
Et retrospektivt studie med skematisk gennemgang af sikkerheden efter
A retrospective, chart review, post authorisation safety study (PASS) shall be
Et revaccinationsprogram skal aftales med den ansvarlige myndighed eller den ansvarlige dyrlæge, der bør tage den lokale epidemiologiske situation med i betragtning
Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Et risikoforhold på mindre end 1 indikerer en fordel for VMP
A hazard ratio less than 1 indicates an advantage for VMP
Et rødgult farvestof (bilirubin), som dannes i leveren, kan forøges (viser sig i blodprøver)
a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests)
et rødgult farvestof (bilirubin), som dannes i leveren, kan forøges (viser sig i blodprøver)
a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests),
Et samlet sårområde, der ikke overskrider 15 % af TBSA, kan behandles med NexoBrid.
A total wound area of not more than 15% TBSA can be treated by NexoBrid.
Et sammenlignende studie (DRCR.net Protocol T) anvendte et doseringsregimen hvor kriterierne for genbehandling var nøje baseret på OCT og ændring i visus.
An independent comparative trial (DRCR.net Protocol T) utilised a dosing regimen based on strict OCT and vision re-treatment criteria.
Et sammenligningsstudie mellem den frysetørrede formulering og den opløste formulering viste bioækvivalens mellem de to formuleringer.
A comparative study between the freezedried and the liquid formulation showed bioequivalence between the two formulations.
Et sandsynligt tilfælde af en toksisk reaktion mod natriumphenylbutyrat (450 mg/kg/dag) er indberettet for en 18-årig anorektisk kvinde, der udviklede metabolisk encefalopati associeret med lactacidose, alvorlig hypokalæmi, pancytopeni, perifer neuropati og pankreatitis.
A probable case of toxic reaction to sodium phenylbutyrate (450 mg/kg/d) was reported in an 18- year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Et sekundært endepunkt var ændring i forhold til baseline i procentdelen af 24-timers perioder uden behov for anfaldsmedicin.
Change from baseline in the percentage of rescue-free 24 hour periods during treatment was a powered secondary endpoint.