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WebA clinical trial application dossier is presented to a Regulatory Agency within a Member State of the European Union, as the basis for authorisation of a clinical trial, as required by EU Regulation 536/2014. The dossier itself comprises the completed clinical trial application form, together with the relevant associated documents ... WebA summary of data relevant to the efficacy of a drug in the intended population for the indication. The summary includes a brief overview of the design of the studies that were conducted to evaluate the efficacy, a tabular listing of all studies that provided information relevant to product efficacy, as well as a comparison and analyses of efficacy results … grand cherokee reviews 2021

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