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.
FDA recommendations for analysis of clinical trials evaluating treatments for weight loss
| Primary efficacy endpoint | Mean: the difference in mean percentage loss of baseline body weight in the active-product versus placebo-treated group
Categorical: the proportion of subjects who lose at least 5% of baseline body weight in the active-product versus placebo-treated group |
| Secondary efficacy endpoints | Should include, but are not limited to, changes in the following metabolic parameters:
|
