Simvastatin efficacy studies were reviewed to define dietary contexts within which simvastatin is most efficacious.
Rigorous efficacy studies are next.
Most efficacy studies have only been short-term.
"There's no data yet on long-term safety and efficacy studies in children," Dr. Softness said.
If this treatment is not too dangerous, efficacy studies will begin involving hundreds of patients.
Nastech has completed two safety and efficacy studies in men, and the second study in women is currently under way, the company said.
On Tuesday, the F.D.A. held a public meeting to review facial fillers and to examine whether their popularization is getting ahead of safety and efficacy studies.
It also stated that the medical literature showed "little evidence regarding liver transplantation in H.I.V. patients and no well-designed safety or efficacy studies".
"When insurers say there are no efficacy studies of liver transplantation for people with H.I.V., that is an absolutely true statement," she said.
Phase III efficacy studies test whether products work, usually with a placebo control group.
SN: You're suggesting combining the two earlier AIDS vaccine efficacy studies that have been done?
