Table 8.

Statistical analysis of the pivotal studies (n = 108)

	Number of pivotal studies (%)
Appropriate statistical analysis
Yes	48 (44.4%)
No	41 (38.0%)
Don’t know (too few details)	19 (17.6%)
Summary statistics at baseline
Yes	71 (65.7%)
With statistical testing	7 (6.5%)
Summary statistics at outcome
No	5 (4.6%)
Yes, for all endpoints	44 (40.7%)
Statistically tested	14 (13.0%)
Not statistically tested	30 (27.8%)
Yes, partially	45 (41.7%)
Statistically tested	31 (28.7%)
Not statistically tested	14 (13.0%)
Yes, only primary	14 (13.0%)
Statistically tested	10 (9.3%)
Not statistically tested	4 (3.7%)
Intention-to-treat analysis
Yes	74 (68.5%)
No	8 (7.4%)
Not applicable / Not reported	26 (24.0%)
Reported with respect to patients lost to follow-up
Reasons for loss to follow-up	70 (64.8%)
Characteristics	2 (1.9%)
Not applicable	8 (7.4%)