1. Center for Drug Evaluation & Research, FDA, Silver Spring, MD 20993, USA
2. Center for Drug Evaluation and Research, FDA, St Louis, MO 63101, USA
3. Building and Fire Research Laboratory, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA
4. Center for Drug Evaluation & Research, FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.