Author Contributions: Drs Strober and Menon had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Strober, McMichael, Krueger, and Shapiro. Acquisition of data: Strober, Menon, McMichael, Hordinsky, Krueger, Panko, and Lustgarten. Analysis and interpretation of data: Strober, Menon, Hordinsky, Siu, and Ross. Drafting of the manuscript: Strober, Menon, and Hordinsky. Critical revision of the manuscript for important intellectual content: McMichael, Hordinsky, Krueger, Panko, Siu, Lustgarten, Ross, and Shapiro. Statistical analysis: Strober, Menon, and Ross. Administrative, technical, and material support: Menon, McMichael, Hordinsky, Krueger, Panko, and Shapiro. Study supervision: Strober. Drafting and design of patient case report form files and protocol: Ross.