TABLE III

Analysis of Variance for Robustness Evaluation

OrganismOne-Sided Lower 95.5% Confidence Limit Log10(MPN)aSite VarianceP > |Z|b
Clostridium sporogenes−0.0500.00930.2522
Propionibacterium acnes0.4150.08570.1780
Escherichia coli0.0920.00001.0000
Pseudomonas aeruginosa0.7710.02180.2366
Staphylococcus aureus0.2640.01380.2227
Bacillus subtilis0.3080.00540.3167
Aspergillus niger0.4900.00140.4544
Candida albicans0.4380.02700.2392
  • a The confidence coefficient selection reflects a 0.5% adjustment for interim analysis. The lower confidence limits are slightly different than those presented in Table II because the standard errors were estimated differently in the robustness model.

  • b P-value for the test whether the site-to-site variance component is significantly different from zero. All are greater than 0.05, indicating that none can be declared significantly different from zero.