H5N1 causes high mortality, especially when untreated. Oseltamivir significantly reduces mortality when started up to 6-8 days after symptom onset and appears to benefit all age groups. Prompt diagnosis and early therapeutic intervention should be considered for H5N1 disease.

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To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines.

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