Week number | |||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schedule of treatments and assessments | Pre-study and randomization | Wk 1 | Wk 2 | Wk 3 | Wk 4 | Wk 5 | Wk 6 | Wk 7 | Wk 8 | Wk 9 | Wk 10 | Wk 11 | Wk 12 | Wk 13-14 | Wk 15 | Wk 16 | Wk 17 | Wk 18-19 | Wk 20 | Wk 21 | Wk 22-24 | Wk 25 | Wk 26 | Wk 27-30 | Wk 31 | Wk 32-38 | Wk 39 |
Wait list Control (Group 1) | y | y | y | y | |||||||||||||||||||||||
Primary Treatment Period | |||||||||||||||||||||||||||
(Groups 2-6) | z | z | z | z | |||||||||||||||||||||||
Primary Treatment Period | |||||||||||||||||||||||||||
(Group 1) | y | y | y | y | |||||||||||||||||||||||
Secondary Treatment Period | |||||||||||||||||||||||||||
(50% of Groups 2 - 6) | z | z | z | z | z | z | |||||||||||||||||||||
Informed Consent | |||||||||||||||||||||||||||
x, y | |||||||||||||||||||||||||||
Baseline Characteristics | x, y | y | |||||||||||||||||||||||||
Primary Outcomes | x, y | x, y | x, y | x | y | x | y | x | y | y | x | y | x | ||||||||||||||
Secondary Outcomes | x, y | x, y | y | x | y | x | y | ||||||||||||||||||||
Adverse Events | z | y | z | ||||||||||||||||||||||||
Potential Co-interventions | x, y | x, y | y | x | y | x | y | ||||||||||||||||||||
Other Measures | x, y | x, y | y | x | y | x | y |