Figure 1. CONSORT (Consolidated Standards of Reporting Trials) Diagram.
aDid not meet inclusion criteria. bDiscontinued treatment due to a severe adverse event (AE) (headache) but continued in the observation period.
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.