Table 6.

Characteristics of the study population in the pivotal studies (n = 108)

	Number of pivotal studies (%)
Study population represents the patient population?
Yes	53 (49.1%)
No	11 (10.2%)
Don’t know	44 (40.7%)
A priori power calculations
Yes, and the required number of inclusions was achieved	51 (47.2%)
Yes, but the required number of inclusions was not achieved	7 (6.5%)
Yes, but it is unclear if the required number of inclusions was achieved	3 (2.8%)
No / Not reported	47 (43.5%)