Figure 1. CONSORT Diagram.

A total of 2 participants from a closed site discontinued the study early, and 4 participants did not enter the treatment phase according to the screening log case report form. These 6 participants were not considered to be discontinued from the study because they were missing study completion case report forms. Off study drug indicates participants who completed the study but discontinued treatment with the study drug prematurely. On study drug indicates participants who received treatment with the study drug until study completion.