Table 6.

Recommendations of guidelines of European Agency for the Evaluation of Medicinal Products⁹ that were met by this study

Guidelines category	Features of present study
Study design	Observational cohort is acceptable
	Control group is necessary and will usually be the chlorofluorocarbon product
	Enrolment of a smaller number of patients in the control group than the study group is acceptable
Patient types and numbers	Enrolment of patients currently using chlorofluorocarbon inhaler acceptable
	Sample was sufficient to test the hypothesis
	No patients were concurrently participating in other postmarketing surveillance studies
	Patient inclusion was as close as practicable to the real prescribing situation
Treatment period	The 3 month treatment period fell within the 3-6 month recommended range
Concomitant medications	Patients may continue with concomitant treatments as per the product data sheet
Reporting parameters	These complied with the guidelines’ recommendations—that is, basic demography, indication, product under study and concomitant medications, date treatment started and stopped, serious adverse events