Figure 1.

Subject disposition

^a2 subjects were ineligible for study entry due to failed entry criteria at baseline. ^b1 subject withdrawn due to an adverse event of somnolence. ^c8 subjects withdrawn due to adverse events of depression (n = 2), hypotension (n = 1), vertigo (n = 1), decreased libido (n = 1), joint sprain (n = 1), sedation (n = 1), and nausea and dizziness (n = 1). ^d6 subjects withdrawn due to adverse events of somnolence (n = 1), fatigue and somnolence (n = 1), increased platelet count (n = 1), dizziness (n = 1), sedation (n = 1), and hypertension (n = 1). ^e6 subjects withdrawn due to adverse events of palpitations and chest discomfort (n = 1), mood swings (n = 1), headache (n = 1), pruritis (n = 1), joint swelling (n = 1), and sleep apnea syndrome (n = 1). mITT, modified intent-to-treat.