Table 1.

Study Design and Sample Size of Epo Randomized Controlled Trial.

	TT10	TT7
Epo	53	49	102
Placebo	48	50	98
	101	99	200

This study used a 2 × 2 factorial design, so patients were included in 1 of the 4 combinations of Epo and TT. The primary paper found no significant interaction between the two variables, Epo and TT thus results were reported separately. The original treatment regimen consisted of one treatment Epo dose or one placebo. For the first 74 patients, the initial dosage regimen was 1 dose given within 6 hours of injury followed by 2 additional doses given every 24 hours; and for the erythropoietin 2 regimen, in 2009, the initial dosage regimen was changed per FDA for the subsequent 126 patients to 1 dose given within 6 hours of injury. Primary results were reported as three randomization groups (Epo1/38, Epo2/64, Placebo/98) (Robertson et al, 2014).