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2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

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Clinical Study OverviewStudy1Study2Study3Study4Study5Study6Study7Study8Study9Study10TotalParthenolide XDisperse blue 106 XBronopol XAdverse <strong>Re</strong>actions – Studies in Subjects 18 Years of Age <strong>and</strong> OlderThe most common adverse reactions (occurring in more than 1% of the study population) were burning, tape irritation, persistent reactions, erythema, <strong>and</strong>hyper/hypo pigmentation. Table 2 summarizes the adverse reactions recorded in ten clinical studies. Subjects’ adverse reactions were recorded on case reportforms by study personnel. Adverse reactions were recorded during subject follow-up visits, which varied between 24 <strong>and</strong>/or 96 hours <strong>and</strong>/or Day 21 [see ClinicalStudies (14)].18

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