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In this section, the inputs to these models and how they are represented in CDISC standards for submission to a regulatory authority are discussed. Model outputs are not currently covered in this section but may be covered in a later release. However, regulatory agencies expect full information to replicate the analysis based in the outputs.

Section 3.4.1 2nd paragraph - consistency of language - change "may be" to "could be" to ensure consistency with sentence in first paragraph