CSF2 and Cowden disease: [14] A randomized, placebo-controlled, phase 2 trial [15], enrolling 124 patients with moderate-to-severe CD receiving either 6 μg/kg of GM-CSF (Sargramostim) daily or placebo subcutaneously for 57 days, failed in achieving the primary outcome (i.e., a reduction in CDAI score of 70 or more).