-Overall, 18% (15–22%) in A vs. 21% (18–0.25%) in B.-Diarrhea, 5.2% (4–7%) in A vs. 4.3% (3–6%) in B.-Elevations in CPK levels were reported in 2.8% (2–5%) in A and only 1.8% (1–3%) in the comparator group. This evidence concerns the gene PIK3C2A and Diarrhea.