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"Dr. Zamboni's studies were unscientific." Generally, it is Dr. Zamboni’s study on the safety and efficacy of the CCSVI Treatment via balloon angioplasty that has been singled out for criticism, largely because it was an “open label” study, which, by definition, means that control groups were not used. However, such criticism is mystifying: at the initial stage of most medical investigations open label studies are commonplace. For example, early pharmaceutical trials usually do not have a control group and are not blinded – they are “open label.” Their goal is to establish safety guidelines, understand technical challenges, evaluate outcomes and outcome measures, determine proper dosing, and provide guidance for future clinical trials. Dr. Zamboni’s open label study addressed many of these same issues. |