Table 1:

Study Plan.

	Baseline Visit (Screening)1	Day 0 Therapy Initiation	Week 1 (± 2days)	Week 4 (± 4days)	Week 8 (± 7days)	Week 12 (± 7days)	Week 32 (± 7days)
GENERAL ASSESSMENTS
Informed consent	X
Randomization		X
Inclusion / Exclusion criteria	X	X
Pregnancy Test (if applicable)		X			X
Demographics, Medical History, Medications2	X	X	X	X	X	X	X
AE assessment	X	X	X	X	X	X	X
VISUAL SYSTEM EXAMS
BCVA (ETDRS letters)	X	X			X	X	X
IOP3 (mm Hg)	X	X	X	X	X	X	X
Slit lamp examination	X	X	X	X	X	X	X
External ocular examination	X	X	X	X	X	X	X
Humphrey 24-2 or 10-2 Visual Field4	X5	X	X6			X7
Dilated fundus ophthalmoscopy	X	X			X	X	X
OCT (retinal thickness)		X			X	X	X
Mitochondrial redox potential		X		X	X	X	X
ERG8		X			X	X	X
STUDY THERAPY
VAS for ocular tolerability		X	X	X	X	X
Study Drug Dispensing9		X		X
Assess Medication Dosing Compliance10				X	X

Schedule of study visits surrounding the 8 weeks of investigational product dosing.

¹Baseline Screening Visit could occur within 4 weeks prior to initiating therapy.

²Demographic information collected at screening including medications taken within the preceding 30 days.

³Intraocular pressure (IOP) testing was performed using Goldmann Tonometer.

⁴Visual field testing was performed using SITA (Swedish Interactive Testing Algorithm) Standard.

⁵Two fields on different days for a total of 3 before initiating treatment.

⁶Three fields within 4 weeks until the end of treatment.

⁷Three fields within 4 weeks until the end of follow-up.

⁸Electroretinography (ERG) performed once at Therapy Initiation (Day 0) visit, at Week 8, at Week 12 and at Week 32.

⁹At Day 0, patient was instructed on self-administering the drug at home.

¹⁰At Week 4 and 8, subject was instructed to return all used and unused investigational product.

AE = Adverse event

BCVA = Best corrected visual acuity

ERG = Electroretinography

IOP = Intraocular pressure

OCT = Optical coherence tomography

VAS = Visual Analogue Scale