“…In comparing against many peerreviewed, published RCTs, with high levels of inadequate, erroneous, and/or incorrect report of per protocol or ITT analysis as well as disagreement, lack of consensus, or standards regarding blinding and blind assessment, there is a sufficient justification and rationale for inclusion of these RCTs and CTs. 1,21,38,[69][70][71][72][73][74][75][76][77][78][79][80] The retrospective requirement of ITT levied on all previous studies, including some otherwise methodological improved smaller trials, can, at times, result in completely discounting evidence that should be considered on some level of the hierarchical ladder. 55,75,76 Furthermore, in many studies with ITT, particularly in systematic reviews of ITT, it is evident that many authors have significant and serious objections to ITT being a sole or the sole arbiter of a valid or legitimate trial (SIGN without modification simply rejects studies that do not use ITT).…”