1 Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. christine.garnett@fda.hhs.gov.
2 Astellas Pharma Global Development, Northbrook, IL, USA.
3 Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
4 Statistik Georg Ferber GmbH, Riehen, Switzerland.
5 Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
6 Biostatistics, Merck & Co., Inc., Gwynedd, PA, USA.
7 Clinical Pharmacology, Pfizer Inc., New York, NY, USA.
8 Stanford University, Stanford, CA, USA.
9 Clinical Reporting, Novo Nordisk A/S, Bagsværd, Denmark.
The original version of this article unfortunately contained an error in Equation 1 under the section "Pre-specified linear mixed effects model". The correct equation has given below.