Patient disposition and study design.
(A) Patient disposition: Ten patients were enrolled and entered the study during the run-in period. All patients completed the treatment and follow-up periods. (B) Study design: The study consisted of 3 periods: 1) a run-in period when patients were treated with the Flolan solution prepared with the existing diluent for up to 30 days, 2) a 4-week treatment period with the new Flolan solution prepared with the reformulated diluent, and 3) a 1-week follow-up period. The patients were continuously treated the new Flolan solution prepared with the reformulated diluent during the follow-up period.