1. Division of Biometrics IX, OB/OTS/CDER, FDA, Silver Spring, MD 10903, USA
2. Department of Public Health Sciences, Penn State Cancer Institute, Hershey, PA 17033, USA
3. School of Public Health, University of Maryland, College Park, MD 20742, USA
4. Department of Mathematics, Drexel University, Philadelphia, PA 19104, USA
5. Department of Preventive Medicine & Biostatistics, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA