Note that this is likely to be the first ever review of mortalty based clinical study reports with case report forms from trials submitted by the sponsor to the regulator as part of its marketing applications. The evidence source for our systematic review is trial reports (clinical study reports [CSR]) released to us by Health Canada, the Canadian regulator, following a Federal Court ruling and European Medicines Agency (EMA) following a freedom of information (FOI) request.[1, 2] The Health Canada data contain.

1. Iacobucci G. Canadian government ordered to release unpublished Tamiflu data in landmark ruling. BMJ. 2018 Jul 13;362:k3112.

2.     Jørgensen L, Doshi P, Gøtzsche P, Jefferson T. Challenges of independent assessment of potential harms of HPV vaccines. BMJ. 2018 Sep 24;362:k3694.