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ICH harmonised guideline: S2(R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use (Current Step 4 version)

This could be explained either by the simulated anthropogenic variability being too low, as suggested by Casado et al

The difference between benefit and harm is clinical rigour

This suggests that non-responders were less severely affected by ME/CFS at baseline, and that the main positive effect of nasal B12 administration occurs in more severely affected patients