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We will ensure allocation concealment throughout the study as none of the investigators will have access to this list until completion of data collection

992 (51%) were first attended at a MT-C and 958 at NSU (49%)

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In some embodiments, the lipid-based drug delivery formulation or composition comprises about 25% v/v or less of any one or more chemical penetration enhancer(s), most preferably from about 2% to 15% v/v, although the exact formulation or composition will vary depending on the presence and amounts of excipients, preservatives, water, pH modulators, and the like included therein