The incidence of overall immune-related adverse events in the study was compared with the data reported in 2 previously published studies ( Table 5 )
Of these, two recommendations were related to the role of the regulator, 14 to the medicines regulatory framework, nine to the medical device framework, three to access to unapproved therapeutic goods and six to regulator functioning and good regulatory framework enablers
[5] These are proof-of-pharmacology studies, not safety or efficacy trials for any indication
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More exciting still, carnitine supplementation had a positive effect on catch-up growth, with the infants regaining their birth weight more rapidly than the placebo group (without carnitine supplementation)
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