Table 3.

Rintatolimod placebo-controlled studies [43,44].

Protocol	No. of patients	Percent female	Study design/data reported
AMP 502 Phase II	92	75	Placebo-controlled, randomized, multicenter Safety and Efficacy Evaluated Placebo (n = 47) or rintatolimod (n = 45): 200 mg for their first four doses, then 400 mg twice a week for 6 months
AMP 502 T Phase II	19	74	Placebo-controlled, randomized, multicenter Safety Evaluated 10 patients received placebo and 9 patients were treated with a higher dosing schedule of rintatolimod (400 mg three times a week)
AMP 516 Phase III	234	73	Placebo-controlled, randomized, multicenter, Safety and Efficacy Evaluated Placebo (n = 117) or rintatolimod (n = 117) 200 mg twice weekly for first four doses, then 400 mg twice weekly for 40 weeks (Stage I)
Total	345	74