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Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.
Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL, Kuebler J, Schriver RC, Santanello NC, Rochester G, Porter JB, Oster M, Mehrotra DV, Li Z, King EC, Harpur ES, Hall DB. Crowe BJ, et al. Among authors: schriver rc. Clin Trials. 2009 Oct;6(5):430-40. doi: 10.1177/1740774509344101. Clin Trials. 2009. PMID: 19846894