Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 Mechanism of phosphodiesterase 5 (PDE5) inhibitors. Appropriate sexual stimuli evoke penile erection by a series of complex biological reactions that result in penile tumescence and rigidity. This mechanism is mediated by nitric oxide. Levels of the second messenger cyclic guanosine monophosphate (cGMP) are regulated by PDE5. PDE5 inhibitors act on PDE5 to inhibit metabolism of cGMP, resulting in increased intracellular concentrations of cGMP, enhanced relaxation of cavernosal and vascular smooth muscle cells, and penile erection. GTP indicates guanosine triphosphate. Reprinted with permission from Eardley and Cartledge. Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 Study design. Asterisk indicates that 20 mg was 2 10-mg tablets of tadalafil. IIEF indicates International Index of Erectile Function; SEP, Sexual Encounter Profile; REF, Residual Erectile Function scale; ASIA, American Spinal Injury Association scale; and GAQ, Global Assessment Question. Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 Patient disposition. Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 Primary measures of efficacy. A, International Index of Erectile Function (IIEF) erectile function domain scores at baseline and after 12 weeks of treatment. The score is the sum of the scores from IIEF questions 1 through 5 and 15. Asterisk indicates P <.001 between treatment groups after 12 weeks of treatment. B, Patient responses to Sexual Encounter Profile diary question 2 (SEP2) and SEP3. Percentages are mean per-patient percentages of yes responses to SEP2 (“Were you able to insert your penis into your partner's vagina?”) or SEP3 (“Did your erection last long enough for you to have successful intercourse?”). Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 International Index of Erectile Function (IIEF) erectile function domain (EF) score 26 or higher after 12 weeks of treatment. Of the 142 patients randomly assigned to tadalafil, 137 (96.5%) had an impaired IIEF-EF score at baseline (<26). Of the 44 patients randomly assigned to placebo, 43 (97.7%) had an impaired IIEF-EF score at baseline. Of the patients with an impaired IIEF-EF score, 74 (54.0%) in the tadalafil group and 5 (11.6%) in the placebo group achieved a normal score after 12 weeks of treatment. Asterisk indicates P <.001 between treatment groups after 12 weeks of treatment. Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 International Index of Erectile Function (IIEF) erectile function domain (EF) score after 12 weeks of treatment by erectile dysfunction (ED) severity. Patients were grouped by ED severity at baseline and then their mean IIEF-EF scores at baseline and end point were determined. P values compare the mean IIEF-EF score at end point of the tadalafil treatment group vs end point score for the placebo. Asterisk indicates statistical significance compared with placebo. Figure Legend:

Date of download: 5/27/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury Arch Neurol. 2007;64(11): doi: /archneur nct70001 Responses to Global Assessment Question 1 (GAQ1) and GAQ2. Asterisk indicates P <.001 between treatment groups for GAQ1 (“Has the treatment you have been taking during this study improved your erections?”) and GAQ2 (“If yes to GAQ1, has the treatment improved your ability to engage in sexual activity?”). Figure Legend: