Q1: Is the study primarily collecting or analyzing data from or about individual humans? YES
Q2: What is the primary mode of inquiry? QUANTITATIVE
Q3: Does the investigator assign one or more interventions? YES
Q4: Are there one or more control groups? YES
Q5: Does the participant act as his/her own control? NO
Q6: Is the unit of assignment a single human? YES
Add additional descriptor here:
Statistical intent (superiority, non-inferiority, equivalence)
Sequence generation (random, blocking, stratification, etc see spreadsheet)
Allocation method (central, sequentially numbered and identical, etc. see spreadsheet)
Are participants assigned to more than one intervention group (ie arm)? (yes = factorial, no=parallel group)
Blinding/Masking (of participant, investigator, outcomes assessor, statistician)
Control group type (active, placebo, sham, usual care, dose comparison, historical?)
Study phase (Phase 0, I, II, III, IV)