Ann: Licensing Webinar and Presentation, page-82

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