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[DOI] [PMC free article] [PubMed] [Google Scholar] 13.Higgins JPT, Green S (eds) Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 (updated March 2011)

In its Complete Response Letter, the regulator said the data was insufficient because a third-party clinical site operator destroyed data source documents for about half of the subjects enrolled in the vaccines trial, according to Reuters