Fig. 1.

Enrollment, randomization, and follow-up. ¥Participants who were consented improperly are not included in this diagram. §The reasons for failing eligibility criteria were “select all that apply,” so one patient may have more than one reason for exclusion. Five patients who did not meet eligibility criteria (three did not meet inclusion criteria and two met exclusion criteria) were randomized. *Reasons for study drug withdrawal were check all that apply. ¶Active gastrointestinal bleeding requiring transfusion of at least 5 units of PRBC’s. ¶¶Such as exacerbation of COPD or asthma, and vasculitis