its critical the recruitment is not rushed and screening and selection remains on point
it is of benefit that the new sites seem to be able to offer potential recruits already diagnosed with insomnia so maybe speeding the dosing process
however chronic insomnia is defined by the inability to initiate or maintain sleep 3 nights per week for a period no less than 3 months = 6% to 15% of the population. for 60% of the identified cohort cognitive behavioral therapy is an effective treatment - you need to filter them out
you also want to identify any with medications currently in play and rule out participation (where possible) until the medication and its affects are no longer present ( yhis includes both prescription and non prescription drugs both oral and topical
rigorous is the word that comes to mind and must be met for all recruited to the dosing speed to the interims should not be a criteria imo and could potentially jeopardise outcomes and those interim data points are a crucial inflection
Sandoz Group AG clearly green lighted the process Avecho has employed and stumped up accordingly
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