A thorough discussion of the known effects of the investigational product(s) in
humans should be provided, including information on pharmacokinetics,
metabolism, pharmacodynamics, dose response, safety, efficacy, and other
pharmacological activities. Where possible, a summary of each completed clinical
trial should be provided. Information should also be provided regarding results
from any use of the investigational product(s) other than in clinical trials, such as
from experience during marketing.