Figure 1. CONSORT Diagram.
Eligibility exclusion reasons are not mutually exclusive. DSMB, indicates data and safety monitoring board; ITT, intent-to-treat, and mITT, modified intent-to-treat.
Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.