| Rationale for definition of the risk period |
|
|
| Based on practical issues |
8 (16) |
4 (9) |
| A valid rationale was given for the definition (at least physiological evidences or reference/expert) |
18 (36) |
23 (51) |
| Risk period characteristics |
|
|
| Each subject had the same risk period duration (for CC) |
41 (82) |
|
| Range duration of the risk period in days (calculated in 44 CC and 39 SCCS articles respectively) |
0,1–364 |
4–1770 |
| Control period characteristics (for CC) |
|
|
| Number of control period(s) was reported |
41 (82) |
|
| Range duration of the control period(s) in days |
0–365 |
|
| Each subject had the same control period(s) duration |
38 (76) |
|
| Control period(s) selection |
|
|
| Only before the risk period |
34 (68) |
|
| Before or after the risk period |
5 (10) |
|
| Others |
5 (10) |
|
| All the observation period but the risk period |
5 (10) |
35 (78) |
| Unclear |
1 (2) |
3 (7) |
| Pre-specified period |
|
7 (16) |
| Risk period(s) and control period(s) had the same time restrictions |
3/5 |
|
