Table 5:

Composite Outcome Of Death Or Survival With Major Morbidity For LOT 1 Only Vs LOT 2 Only¹

	Lot 1 Use Only				Lot 2 Use Only				Inositol Lot
Outcome	Inositol (N=124)	Placebo (N=119)	RR (95% CI)	P	Inositol (N=137)	Placebo (N=148)	RR (95% CI)	P	RR (95% CI)	P
NDI or Death Prior to Follow-up	75/116 (65%)	59/115 (51%)	1.29 (1.05 to 1.60)	0.02	72/132 (55%)	80/140 (57%)	0.93 (0.76 to 1.14)	0.49	0.85 (0.69 to 1.04)	0.11
Any ROP or Death Prior to Follow-up	99/124 (80%)	84/119 (71%)	1.14 (1.00 to 1.29)	0.05	103/137 (75%)	110/148 (74%)	1.01 (0.88 to 1.15)	0.91	0.88 (0.76 to 1.02)	0.09
Death Prior to Follow-up	31/124 (25%)	19/119 (16%)	1.50 (0.91 to 2.46)	0.11	27/137 (20%)	20/148 (14%)	1.45 (0.86 to 2.45)	0.17	0.80 (0.52 to 1.25)	0.34
Moderate or Severe NDI2	44/ 85 (52%)	40/ 96 (42%)	1.23 (0.90 to 1.69)	0.19	45/105 (43%)	60/120 (50%)	0.86 (0.65 to 1.14)	0.29	0.83 (0.61 to 1.11)	0.21
Any ROP3	74/101 (73%)	67/102 (66%)	1.10 (0.92 to 1.31)	0.31	79/119 (66%)	94/133 (71%)	0.95 (0.80 to 1.12)	0.52	0.91 (0.77 to 1.08)	0.27

NDI, neurodevelopmental impairment; ROP, retinopathy of prematurity; P, P-value

Robust Poisson regression adjusting for center where possible and GA strata were used to obtain p-values and estimated adjusted relative risks and 95% confidence intervals. Lot 1 was used as the reference group for the Inositol lot comparison.

¹Excludes lost to follow-up participants

²Occurrence of any of the following: GMFCS level II or higher, Bayley III cognitive composite score < 85, Bayley III motor composite score < 85, unilateral blind or bilateral blind, permanent hearing loss that does not permit child to understand directions of the examiner and communicate despite amplification with cochlear implant or hearing aid

³Includes any report of ROP in the GDB NG-03 form, Follow-up NF-04 form, INS 3–14 Follow-up form (ophthalmologist diagnosed or treated ROP), or a documented finding of ROP on any ophthalmologic exam during the initial INS follow-up