Table 3.

Compared HYPO (severe and symptomatic) number per person between groups and at different time points, defined as: A = T−6/T0 (pre-randomization period); B = T0/T+6 (first follow-up period); C = T+6/T+12 (second follow-up period)

Groups	HYPOs	T−6/T0 (A = baseline) Episode n	T0/T+6 (B period) Episode n	T+6/T+12 (C period) Episode n
Control group (n. 359)	Severe n Mean/person	89 1.61	72* 1.46	80 1.66
	Symptomatic n Mean/person	316 1.12	277* 1.22	311 1.08
Total		405	349	391
Intervention group (n. 359)	Severe n Mean/person	91 1.56	38** 1.52	12***&& 2.10
	Symptomatic n Mean/person	308 1.10	59** 1.73	25***&& 2.27
Total		399	97	37

B vs. A: *p < 0.05; **p < 0.01: ***p < 0.001; C vs. A: && p < 0.01