Table 2.

Hierarchical Testing of Coprimary and Key Secondary Efficacy Endpoints in the Modified Intention‐to‐Treat Population

Endpoint	Solriamfetol, Treatment Difference from Placebo, Least Squares Mean (95% CI)
	300 mg	150 mg	75 mg
Maintenance of Wakefulness Test, min	10.14 (6.39, 13.90), p < 0.0001	7.65 (3.99, 11.31), p < 0.0001	2.62 (−1.04, 6.28), p = 0.1595
Epworth Sleepiness Scale	−4.7 (−6.6, −2.9), p < 0.0001	−3.8 (−5.6, −2.0), p < 0.0001	−2.2 (−4.0, −0.3), p = 0.0211
Patient Global Impression of Change (%)a	45.1 (29.51, 60.67), p < 0.0001	38.5 (21.86, 55.19), p < 0.0001	28.1 (10.80, 45.48), p = 0.0023b

A fixed hierarchical testing procedure was used to correct for multiplicity, starting with the highest solriamfetol dose for the coprimary endpoints and followed by the key secondary endpoint; testing proceeded in that order for each subsequent lower dose, with statistical significance claimed only for those outcomes above the break in the hierarchy.

^aPatient Global Impression of Change is a patient self‐reported, 7‐point assessment, ranging from “very much worse” to “very much improved.”

^bNominal p value, because it is below the hierarchical break.