Of the 110 articles identified using the search strategy, 35 were selected that met all inclusion criteria. Of the 35 references used as evidence, 35 are categorized as therapeutic including 14 well-designed studies (Phase II randomized and Phase III), 12 moderately well-designed studies that account for most common biases (matched cohort and Phase II studies), 7 studies with design limitations (retrospective reviews), and 3 meta-analyses. Variant cases were developed as examples to illustrate p