Примери за използване на Submit the results на Английски и техните преводи на Български
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In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma,the MAH will submit the results of study APN311202v3.
Iranian students must submit the results of their National Exam, also known as“concours,” and have a successful interview with the members of the Selection Committee.
Efficacy and safety, the MAH should submit the results of a study based on.
Verify on the ground all allegations concerning the destruction of and damage caused to EU-funded structures andprojects in the occupied territory, and submit the results to Parliament;
Daklinza, the MAH shall conduct and submit the results of a prospective safety.
Calls on the EEAS and the Commission to verify on the ground all allegations concerning the destruction of and damage caused to EU-funded structures andprojects in the occupied territory, and submit the results to Parliament;
Harvoni, the MAH shall conduct and submit the results of a prospective safety.
Post-authorisation efficacy study(PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy,the MAH should conduct and submit the results of the Phase 2, open-label study(NURTURE(SM201)).
English proficiency: Applicants whose first language is not English must submit the results of an English test taken within the two years preceding the application deadline.
Post-authorisation efficacy study(PAES): In order to evaluate the long term efficacy and safety of nusinersen in symptomatic patients with spinal muscular atrophy,the MAH should conduct and submit the results of the Phase 3, open-label extension study(SHINE, CS11).
In order to investigate the safety and efficacy of long-term treatment with Iblias,the MAH will submit the results of the ongoing study“13400- Leopold Kids extension”.
Tablets are crushed, the MAH shall conduct and submit the results of a safety study.
In order to follow-up on the efficacy of Alofisel,the MAH should submit the results of a Phase III randomised double-blind, placebo-controlled study Cx601-0303 investigating a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients.
In order to investigate the safety andefficacy of Iblias in previously untreated patients the MAH will submit the results of the ongoing study“13400- Leopold Kids Part B”.
In order to confirm the efficacy and safety of OCALIVA,the MAH should conduct and submit the results of study 747-401, a double-blind, randomised, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of OCALIVA in patients with PBC and moderate to severe hepatic impairment.
In order to investigate the cardiovascular risk in association with lesinurad exposure, mainly in patients with a history of cardiovascular disorders,the MAH shall conduct and submit the results of an observational prospective study according to an agreed protocol.
Taking all available data into account,the PRAC was of the view that MAHs should conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs,the MAH should conduct and submit the results of a noninterventional post-authorisation safety study according to an agreed protocol.
In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material(study 19-514).
In order to verify the impact of the intervention on clinical outcome or disease progression and to confirm previous efficacy assumptions,the MAH should conduct and submit the results of the ongoing prospective, open-label, multicentre study.
In order to collect long-term data on clinical efficacy and safety,the MAH should submit the results of a study based on data deriving from a registry of patients with hypoparathyroidism and who are treated with NATPAR.
In order to collect further field data, related to both safety and efficacy, from batches that have been released by use of the updated potency assay,the marketing authorisation holder shall conduct and submit the results of a surveillance study.
Zalmoxis, the MAH should conduct and submit the results of study TK011 using the. .
In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyRin patients with CP-CML, the MAH should conduct and submit the results of a doseranging study.
In order to evaluate the recurrence of hepatocellular carcinoma associated with OLYSIO,the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
In order to investigate the long-term effects of enzalutamide on Overall Survival and relevant secondary endpoints in adult men with high-risk non-metastatic castration-resistant prostate cancer,the MAH should submit the results of the MDV3100-14(PROSPER) efficacy study.
In order to evaluate the recurrence of hepatocellular carcinoma associated with Maviret,the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.