Table 2.

A timeline of study visits and the outcome tests performed at each visit. Safety bloods include renal function (urea, creatinine, and electrolytes), liver function (aspartate transaminase, alanine transferase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase), thyroid function (thyroid stimulating hormone free thyroxine), and creatine kinase.

Outcome		Measure	Weeks
			0	1	2	3	4	6	8	10	12	16
Primary outcome
	ICP	Lumbar puncture	X								X
Secondary outcomes
	Anthropometric measures	Body mass index, blood pressure, waist/hip, body composition	X								X	X
	IIH symptoms	Pulsatile tinnitus, visual loss, diplopia, visual obscurations	X								X	X
	Visual function	Visual acuity, contrast sensitivity	X								X	X
		Humphrey visual field (24-2)	X								X	X
	Papilledema	Optical coherence tomography	X								X	X
		Retinal photographs	X								X	X
	Headache	HIT-6, headache index, analgesia use	X								X	X
	Medical assessment	History, +/- examination, compliance	X	X	X	X	X	X	X	X	X	X
		Safety bloods	X	X			X		X		X	X
		Pregnancy test	X	X			X		X		X	X
Exploratory outcomes
	Global 11β-HSD1 activity	24-hour urine	X	X			X		X		X	X
	Hepatic 11β-HSD1 activity	Prednisone to prednisolone measurements in serum	X								X
	Adipose 11β-HSD1 activity	Subcutaneous adipose biopsy	X								X
	Body habitus	DXA	X								X
	Pharmacokinetic analysis	Plasma and CSF	X	X							X