Table 2.

Schedule of Procedures

	Screening		Week from Randomization
Procedure	SV1.0	SV2.0	0	4	12	24	28	36	48	52	60	72
Informed Consent	●
Eligibility and randomization			●
Medical History	●
Medical Follow-up				●	●	●	●	●	●	●	●	●
Assessment of all medications	●			●	●	●	●	●	●	●	●	●
Vital Signs	●	●		●	●	●	●	●	●	●	●	●
Physical and digital rectal exam	●											●
Prostate serum antigen (PSA)	●					●			●			●
Uroflow measurement	●	●			●	●		●	●		●	●
Hematology, Serum chemistries, EKG	●				●	●		●	●		●	●
Urinalysis	●											●
Serum for banking	●											●
Study drug administration and compliance			●		●	●		●	●		●	●
Discontinuation of study drug												●
Questionnaires
Jenkins Sleep Dysfunction Scale			●			●			●			●
Erectile Function			●			●			●			●
Ejaculatory Function			●			●			●			●
Bladder Function		●			●	●		●	●		●	●
AUASI Score	●	●			●	●		●	●		●	●