Study Design and Methods
death
EVENTS, EVENT
Details of the INCREASE study procedures and end points have been reported previously.The coprimary end points of this study were the proportion of patients who experienced a clinical worsening event or who demonstrated clinical improvement between weeks 4 and 16 in each group. Clinical worsening was defined by one of four events: a 15% decrease in the 6MWD, hospitalization for cardiopulmonary cause, lung transplantation, or death. Clinical improvement was defined by a 15% increase in the 6MWD by 16 weeks accompanied by a 30% reduction in N-terminal prohormone of brain natriuretic peptide in the absence of any clinical worsening events.