Pharmacodynamics
nonadherence, tuberous sclerosis
SECONDARY, TUBEROUS SCLEROSIS
For the first coprimary efficacy end point (all participants), least squares (LS) mean (±SEM) reduction from baseline in spot urine osmolality (premorning dose) after 1 week of daily dosing was greater in the tolvaptan arm (−390 [28] mOsm/kg) than in the placebo arm (−90 [29] mOsm/kg; Coprimary, key secondary, and related outcomesLS, least squares; 95% CI, 95% confidence interval; MRI, magnetic resonance imaging; htTKV, height-adjusted total kidney volume.For the baseline visit, A participant with tuberous sclerosis and hence notably larger kidney volume was excluded.Participants with pharmacokinetically verified nonadherence were excluded.