| uPOD+PT | uPOD | Relative Risk (95% CI) |
---|---|---|---|
FAAM | |||
 ITT analysis (uPOD+PT, n = 48; uPOD, n = 47) | |||
  6 wk | 36 (75) | 31 (66) | 1.1 (0.9 to 1.5) |
  6 mo | 43 (89.6) | 38 (80.9) | 1.1 (0.9 to 1.3) |
  1 yr | 44 (91.7) | 42 (89.4) | 1 (0.9 to 1.2) |
 PP analysis (uPOD+PT, n = 38; uPOD, n = 41) | |||
  6 wk | 29 (76.3) | 26 (63.4) | 1.2 (0.9 to 1.6) |
  6 mo | 37 (97.4) | 33 (80.5) | 1.2 (1.0 to 1.4)a |
  1 yr | 36 (94.7) | 38 (92.7) | 1 (0.9 to 1.1) |
NPRS | |||
 ITT analysis (uPOD+PT, n = 48; uPOD, n = 47) | |||
  6 wk | 31 (64.6) | 16 (34) | 1.9 (1.2 to 2.3)a |
  6 mo | 32 (66.7) | 27 (57.4) | 1.2 (0.8 to 1.6) |
  1 yr | 41 (85.4) | 31 (66) | 1.3 (1.0 to 1.6)a |
 PP analysis (uPOD+PT, n = 38; uPOD, n = 41) | |||
  6 wk | 26 (68.4) | 15 (36.6) | 1.9 (1.2 to 3.0)a |
  6 mo | 30 (78.9) | 23 (56.1) | 1.4 (1.0 to 1.9)a |
  1 yr | 34 (89.5) | 28 (68.3) | 1.3 (1.0 to 1.7)a |