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All were randomised, parallel group, multinational trials of 40 or 52 weeks treatment duration at the primary timepoint that compared the efficacy and safety of once weekly tirzepatide 5, 10 or 15 mg versus placebo or active comparator in adults with T2D
The condition primarily manifests as megaloblastic anemia with recurrent diarrhea, mouth ulcers, recurrent infections, anemia and loss of appetite, which typically occur in the first months of life
The time of evaluation was considered a within-subject factor and intervention state (L- carnitine, fat emulsion, L- carnitine plus fat emulsion, and control), a between-subject factor
ICH Q14 describes science- and risk-based approaches for developing analytical procedures, while ICH Q2(R2) describes validation principles for analytical procedures [21] [19]