Medication schedule and adverse event reporting
ADVERSE EVENTS
Instructions were provided to caregivers on site during drug allocation visits (Wk 0 and 3) consistent with our previous published guidelines [Monitoring of potential adverse events was by telephone during mid-intervention for the treatment phase (i.e., wk 9) and at treatment completion (wk 15). Caregivers (and the child when appropriate) were asked open-ended questions about adverse events or side effects that had occurred during the treatment period. Caregivers were also asked to complete a daily diary reporting any side effects of nasal spray administration. This diary was also used to evaluate treatment compliance and was reviewed during Visit 3. Serious adverse events were reported to the local institutional review board.