Figure 1.

Study CONSORT diagram

A schematic outlining the number of individuals who were assessed for eligibility, randomized, and included in the analyses. Thirteen people declined to participate. Approximately, 79% of individuals assessed for eligibility consented to participate and were subsequently randomized. Of the 50 individuals randomized to each group, data from 12% (n = 6) of the IPE group and 6% (n = 3) of the usual care group were not analyzed for the primary biomarker endpoint based on the lack of paired biomarker data.