Statement of protocol design (e.g., blinding, control group)
Characteristics of study data collection site(s)
Inclusion/exclusion criteria
Randomization/stratification plan
Definition of participants (e.g., screened, enrolled, randomized, training, treated, drop out, lost to follow-up)
Intervention definition
Reasons to discontinue participation
Reasons to change treatment regimen
Outcome measures
Sample size
Key adherence variables
Key safety variables (e.g., BP, pulse, liver function tests)
Data analysis plan
Interim analysis plan