Description of selection of subject was adequate | 0–3 |
Description of patients screened was provided | 0–3 |
Inclusion criteria for study included | 0–2 |
Exclusion criteria for study included | 0–2 |
Withdrawals and reason for withdrawal were described | 0–3 |
Therapeutic regimen definition | 0–3 |
Control appearance | 0–2 |
Randomisation was blinded | 0–10 |
Patients were blinded to treatment group | 0–8 |
Investigators were blinded to treatment group | 0–8 |
Power calculations (sample size requirements) | 0–4 |
Adequacy of randomisation was evaluated | 0–4 |
Adequacy of blinding was evaluated | 0–3 |
Compliance with treatment was assessed | 0–3 |
Measure of outcome of active therapy was made | 0–2 |