Specific criteria/consid- erations for inclusion of new data include the following: publication in a peer-reviewed journal; large, randomized, placebo-controlled trial(s); nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions, including observational studies and meta-analyses; strength/weakness of research methodology and findings; likelihood of additional studies influencing current findings; impact on current and/or likelihood of need to develop new performance measure(s); request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of industry relationships or other potential bias; number of previous trials showing consistent results; and need for consistency with a new guideline or guideline updates or revisions. In analyzing the data and developing recommendations and supporting text, the writing group uses evidence-based method- ologies developed by the Task Force.1 The Class of Recommen- dation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective and in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing group reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C using specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and ranked as LOE C. When recommenda- tions at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. 