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The power to detect differences between the study groups is larger than what is projected here as we will measure most of the outcomes more than once and also use these repeated measurements in the same analyses, adjusting for interdependence within a child using mixed effects models, generalised estimating equations or other appropriate methods

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It is necessarily important to perform each and every process of manufacturing according to guidelines proposed by good manufacturing practices (GMP)

Dispose of the syringe safely in a sharps container