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It means the agency did not have reliable human data showing what exposure they produce, whether they help, how often adverse effects occur, or how product variability affects results

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Inclusion criteria required participants to be over age 18, read and speak English, have a Hoehn & Yahr score between 2 and 3 (bilateral disease, not severely disabled), and have three or more of the required positive criteria for the diagnosis of definite PD from Step 3 of the UK Brain Bank Diagnostic Criteria for PD

For practical purposes, this distinction matters less than you might think