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.
Trial profile and participant flow. The number of patients and the actual study profile are shown in each block. A total of 53 patients were randomized, and all 53 patients were included in the safety and primary efficacy analysis (intention-to-treat population). The per-protocol (PP) analysis comprised 46 patients. ITT, intention to treat.
