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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Drug: Placebo to indacaterol Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler SDDPI.
FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week Standardized FEV1 AUC 5 minutes-4 hour post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Each domain is scored from -3 major deterioration to 3 major improvement to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline.
A 1 unit difference in the TDI focal score is clinically significant. Quality of Life Assessment With St. The total score is 0 to with a higher score indicating greater impairment of health status. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant.
The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant.
Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment [ Time Frame: Up to 12 weeks ] A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication.