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This concern was based on comments from an expert reviewer appointed by this IRB, and we are dealing with this concern, in part, by measuring functional motor behaviour by the TIMP when the children are 45 days in the first 100 children

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For compounds requiring acetic acid acidification for solubility and including some hydrophobic peptides , Bacteriostatic Water may need to be acidified with sterile acetic acid to achieve the required pH for dissolution before addition to the lyophilised compound