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Since clusters are geographically separated from one another and families within each cluster are typically non-mobile, contamination is unlikely but to further avoid contamination, unused kit components will be collected from participants during their last data collection visit (day 28 of newborn's life).
Within a week of each projected follow-up data collection visit, participants were asked to complete the battery of questionnaires collected at baseline.
All participants were asked about their physical activity level and sports participation status at their post-HIRREM data collection visit and 1 to 3 months afterward.
Participants were asked about their physical activity level including participation in competitive athletics at two time points: their post-HIRREM data collection visit and in the course of additional follow-up data collection (phone call, email, or office visit) that took place 1 to 3 months after the post-HIRREM data collection visit.
These recordings were obtained at the pre-HIRREM enrollment visit, just prior to the assessment of the pattern of brain electrical frequencies and amplitudes, and again during the post-HIRREM data collection visit.
Self-reported symptoms were recorded on the day of the HIRREM assessment and also during a post-HIRREM data collection visit that took place a mean of 19.5 (SD 23.1) days following the last HIRREM session, with sensitivity to academic scheduling constraints.
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The majority of data (79 of 95 data collection visits; 83%) were collected by the technician (MR) and/or one of the pharmacists (SS); these two researchers independently examined items dispensed for the same 40 patients at the beginning of the study to assess inter-rater reliability.
Subsequently, subjects undergo a series of HIRREM sessions, followed by up to two post-HIRREM data collection visits (see below for details).
For seven participants, reaction testing was performed during the baseline assessment and post-HIRREM data collection visits using a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance [32].
Therefore, monthly data collection visits were deemed necessary.
Follow-up data collection visits occurred at 4 and 9 months after randomization.
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