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Peptide Evidence, Safety and Regulation in Canada

1 1,8 Polysomnography (sleep labs) Sleep diaries (patient reports) N=1006 1-month treatment period Treatment arms DAYVIGO 5 mg DAYVIGO 10 mg Active comparator (zolpidem ER 6.25 mg) Placebo Males ≥65 years of age Females ≥55 years of age Median age: 63.0 years 86.0% female 73.0% white 45.0% ≥65 years of age 1 Sleep diaries (patient reports) N=971 6-month placebo-controlled treatment period with 6-month parallel-group extension period Treatment arms DAYVIGO 5 mg DAYVIGO 10 mg Placebo Adults ≥18 years of age Median age: 55.0 years 68.0% female 71.5% white 28.0% ≥65 years of age All patients received instructions consistent with principles of good sleep hygiene

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doi: 10.1073/pnas.0607965104