Figure 1.

CONSORT diagram of patient disposition. ITT analysis set included all patients who were randomly assigned to treatment. CE analysis set included all patients in the ITT population who: (i) received ≥80% of the total expected doses of the assigned study drug or were clinical failures and received ≥4 doses of study drug; (ii) did not receive any concomitant, systemic antibacterial therapy with activity against the identified pathogen; and (iii) had no major protocol deviations. MITT analysis set consisted of all patients in the ITT analysis set that had bacterial pathogens known to cause ABSSSI at baseline. ME analysis set included all patients in the MITT population who met the criteria established for the CE analysis set. SAF, safety; TC, telephone call.