Table 2.

Study Design and Schema

ASSESSMENT	Fluid Status (Height, Weight, Hx, Exam)				Pregnancy Test (Urine)	Safety Tests (Na, K)	Coagulation Tests (VWF,F.VIII, mRNA)	Hematology Tests (H/H, Platelets)	Diary
PRE-TRIAL  In-Hospital Assessment  Day 1-4	X	X	X	X	X	X	X	X	-
DURING TRIAL  In-Hospital Assessment  Day 1-4	X	X	X	X	X	X	X	X	-
POST-TRIAL  Outpatient Assessment  Day 10 after rhIL-11	X	X	X	X	-	X	X	X	X

Fluid status, including height, weight, physical exam for congestive heart failure and papilledema, and clinical assessment for finger orankle swelling, were performed in-hospital. Urine pregnancy tests were performed in females daily in-hospital before taking rhIL-11. Safety Testsincluded Na+ and K+; Coagulation Tests included VWF assays, VIII assays, closure times, and VWF mRNA; and Heme Tests included hemoglobin, hematocrit (H/H) and platelets. All assessments were repeated day 10 post rhIL-11 in the outpatient clinic. All symptoms and concomitant medications were collected by study subjects and reviewed with nurses at the day 10 outpatient visit.