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Description
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After one-third of the study participants have been enrolled and completed follow-up, the DSMBs will review the data and make recommendations concerning continuation, modification or termination of the study due to unexpectedly large beneficial effects or serious side effects and can suggest extension of the trial should the primary outcomes occur less often than anticipated

Podruje lijekova najdetaljnije je i najstroe regulirano propisima i smjernicama na razini Europske unije te ih se HALMED u potpunosti pridrava

Larger, well-controlled human clinical trials would be needed to determine safety and effectiveness in clinical settings
