The following points should be considered:
A clear description of the clinical protocols must be given,
including:
description of the population studied;
specific inclusion/exclusion criteria;
dosage and duration of study and comparative drug
therapy;
times of initial, on-therapy and follow-up microbiological
and clinical assessments, visits and test of cure
evaluability criteria;
definitions of 'clinical'and 'bacteriological' response.
When the category 'improved' is used as a clinical outcome,
this must be clearly defined:
If adjunctive therapy is permitted, this must be so stated.