Примери за използване на Was not demonstrated на Английски и техните преводи на Български
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Bioequivalence was not demonstrated for each subcomponent.
The CHMP therefore concluded that the comparability of patients to healthy volunteers was not demonstrated.
The efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Children and adolescents CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.
In the pivotal clinical trial, efficacy was not demonstrated and safety was not established(see section 5.1).
In a third short-term placebo-controlled monotherapy trial with Seroquel XR in children and adolescent patients(10-17 years of age)with bipolar depression, efficacy was not demonstrated.
Superiority of dapagliflozin over placebo was not demonstrated for MACE(p= 0.172).
No study was conducted with the combination in the proposed indication and thus the clinical benefit of the association was not demonstrated.
In the pivotal clinical trial,efficacy was not demonstrated and safety was not established(see section 5.1).
The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose,but equivalence was not demonstrated.
The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years.
Bioequivalence between Loratadine Sandoz 10 andthe reference product was not demonstrated for the parent compound.
Efficacy was not demonstrated in patients aged 6 to 11 years with CF who have an R117H mutation while only two adolescent patients were enrolled in study 6(see section 5.1).
Study 3004 also included patients with schizoaffective disorder and efficacy was not demonstrated in the schizophrenia subgroup.
Efficacy of Sycrest was not demonstrated in an 8-week, placebo-controlled, double-blind, randomized, fixed-dose trial in 306 adolescent patients aged 12-17 years with schizophrenia at doses of 2.5 and 5 mg twice daily.
Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Pirlimycin has been shown to accumulate in polymorphonuclear cells, however,intracellular killing of Staphylococcus aureus was not demonstrated.
Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
The Court also found cases of forest roads used for the economic exploitation of the forests where the particular benefit for fire prevention was not demonstrated.
Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
In the pivotal trials conducted by the MAH, a dose higher than the dose proposed was used and, as very limited final height data is available,the clinical relevance of the effect was not demonstrated.
Netarsudil demonstrated clinically relevant reductions in IOP at all timepoints, however non-inferiority to timolol was not demonstrated in this population with baseline IOP≥25 mmHg and< 30 mmHg(Table 2).
The CHMP considered that this was not demonstrated by the data provided due to the questionability of the reliability of study EN3267-001, because the data does not allow the evaluation of the bioavailability of the two formulations, and because the pooled analysis cannot be endorsed.
CHAMPIX is not recommended in paediatric patients because its efficacy in this population was not demonstrated(see sections 4.2 and 5.1).
For some types of the implemented operations key eligibility requirements could not be verified due tolack of documenta- tion. The Court also found cases of forest roads used for the economic ex- ploitation of the forests where the par- ticular benefit for fire prevention was not demonstrated.
Poland considered that the clinical superiority of Tobramycin VVB vs. the orphan-designated medicinal product TOBI Podhaler 28 mg inhalation powder(hereinafter“TOBI Podhaler”) was not demonstrated, therefore derogation as per Article 8(3) of Regulation(EC) No 141/2000 was not fulfilled and a marketing authorisation as proposed by the RMS could not be granted.
The MAHs disagreed with the CHMP that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak andthat the efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
In another large randomised double-blind trial(POET) conducted in the Czech Republic and in Slovakia, 4,907 infants(ATP cohort) received either the 11-valent investigational vaccine(11Pn-PD)containing the 10 serotypes of Synflorix(along with serotype 3 for which efficacy was not demonstrated) or a control vaccine(hepatitis A vaccine) according to a 3, 4.
There are a huge number of items available today that claim to help in weight reduction,however, are not demonstrated to work.
In view of the problems of quality of data and frequent misreporting by traders themselves,the benefits of such an obligation are not demonstrated.