| Yes n (%) | No n (%) | Unclear n (%) |
---|---|---|---|
Adequate generation of allocation of sequence | 77 (58.3) | 0 | 55(41.7) |
Concealment of treatment allocation | 46 (34.8) | 0 | 86 (65.2) |
Details of intervention used in each group available | 125 (94.7) | 0 | 7 (5.3) |
Care providers' experience or skill in each arm appropriate | 3 (2.3) | 0 | 129 (97.7) |
Participants adequately blinded | 23 (17.4) | 63 (47.7) | 46 (34.9) |
Care providers adequately blinded | 16 (12.1) | 74 (56.1) | 42 (31.8) |
If patients and/or care providers were not adequately blinded: | Â | Â | Â |
   All other treatments and care were the same in each group | 97 (73.5) | 5 (3.8) | 9 (6.8) |
   Withdrawals and lost to follow-up were the same in each group | 46 (34.8) | 6 (4.5) | 61 (46.2) |
Outcome assessors adequately blinded to assess the primary outcomes | 39 (29.5) | 44 (33.3) | 49 (37.1) |
If outcome assessors were not adequately blinded: | Â | Â | Â |
   Specific methods were used to avoid ascertainment bias | 2 (1.5) | 13 (9.8) | 76 (57.6) |
   Follow-up schedule was the same in each group | 105 (79.5) | 2 (1.5) | 23 (17.4) |
   Main outcomes analyzed according to the intention-to-treat principle | 105 (79.5) | 17 (12.9) | 10 (7.6) |