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In the SURMOUNT trials, nausea affected 12 to 18 percent of participants at lower doses and higher percentages at escalating doses

The GLAS algorithm will need to be validated and refined in larger cohorts and tested in longitudinal studies for differentiating between stable versus advancing liver disease over time

10.3390/ijerph17072227 282

We do not believe a second or longer restatement process is needed for Part B rebatable drugs to account for ASP restatements in the ordinary course, because, as described previously, the reconciliation timing as set forth at 427.501(d)(1) would allow sufficient time for ASP restatement and claims run-out before the reconciliation as set forth in 427.501(d)(1) would occur

Ono H, Sakamoto A, Sakura N