Table 2.

Endpoints and assessment timing

Endpoint	Timing of Assessment
Primary endpoint
SOT	Baseline, end of each stage, and every 3 wk during stages 2 and 3
Secondary endpoint
6MWT	Baseline, end of stage 1, every 3 wk during stages 2 and 3
DGI	Baseline, end of stage 1, every 3 wk during stages 2 and 3
Exploratory endpoint
NSI	Baseline, end of each stage
BSI 18	Baseline, end of each stage
PSQI	Baseline, end of each stage
HDI	Baseline, end of each stage

Abbreviations: BSI, Brief Symptom Inventory; HDI, Headache Disability Index; NSI, Neurobehavioral Symptom Inventory.