Sample size
HAND, GDS
We enrolled 54 participants for each treatment arm to account for about a 10% loss to attrition. The GDS has been shown to improve by a mean of approximately 0.13 in patients with mild to moderate (> 0.25 to < 0.75) and 0.6 in patients with severe HAND (> 0.75) in the population we studied (Joska et al. 