Comment Summary

The results of this study will be submitted to the FDA. What action do you think the FDA should take based on this study?
#	Response Date	Other (please specify)
1.	3/3/2008 3:00:00 PM	Include pharmacogenomics and prior episodes
2.	3/3/2008 4:28:00 PM	Mandate publication of all drug company sponsored trials
3.	3/5/2008 4:49:00 AM	Studies should have minimal exclusion criteria. Because of the very nature of RCTs the patients are not representative of the actual clinic population. While RCTs are gold standards for establishing efficacy, next level trials have to be simple, pragmatic and closer to actual clinic practice.
4.	3/5/2008 6:07:00 PM	at most consider adding additional info to package insert