Table 6.

Results of the bag storage analytical study per storage condition.

Expected DOB	Storage condition	Parameter	SD value	95% CI	CV (%)
DOB: 3.3‰
	15°C	Overall repeatability	0.57	[0.45–0.78]	15.0
		Between days precision	0.57	[0.45–0.68]	15.0
	35°C + 70% humidity	Overall repeatability	0.60	[0.48–0.82]	16.9
		Between days precision	0.60	[0.47–0.72]	16.9

DOB: delta over baseline; CI: confidence interval; CV: Coefficient of Variance; SD: standard deviation.