ICH Harmonized Tripartite Guideline Maintenance of the ICH Guideline on Clinical Safety Data Management. Data Elements for Transmission of Individual Case Safety Reports E2B(R2) Current Step 4 version dated 5 February 2001. Available at: https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf . Accessed February 1, 2020
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