Table 1.

Schedule of assessments.

Parameter	Screening	Treatment														EOT
Visits	1	2														3
Day (±days)	24–48 h	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15
Written Informed Consent	X
Inclusion/Exclusion Criteria	X
Medical and surgical History	X
Physical Examination	X
Vital signs	X				X				X			X				X
Demographic Information	X
IP administration		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Urine pregnancy test (In case of a female subject)	X
Chalder Fatigue Scale	X				X				X			X			X	X 1
Patient Diary		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Adverse events		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant Medications		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

¹ Collection of Completed Questionnaires.