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135StudyEDDetails 8 Study Design Setting ScaleAgeMean Serum Test Cut-offComorbidity(SD)Levels time (LH/FSH)RangeNormalRange(LH/FSH)Assay(before11am)Table 9: Prevalence of Primary or Secondary Hypogonadism in Men with Erectile Dysfunction (total serum levels of LH and FSH)Study details 10 Study design SettingTMean(SD)PRLMean(SD)LHMean(SD)FSHMean(SD)nLH/FSHN %TesttimeCut–off(TT)NormalrangeAssaySecondary hypogonadism (Low levels of LH and/or FSH)Bunch 2002(USA)Retrospective*Outpatients177.73 ±78.36ng/dLNR6.8±9.1mIU/mlNR↓LH:29 ‡ 6643.9 NR<13mIU/mlNRRIAEl-Sakka 2005(Egypt)ProspectiveAndrology clinic1.8±0.9ng/mL34 ± 13.9ng/mLNRNR↓LH/FSH:2112481.68 morning NR NR ECLAPrimary hypogonadism (High levels of LH and/or FSH)Akpunonu 1994(USA)ProspectivePrimarycareclinics14±5.1nmol/L6.3 ± 6.5mcg/L10.6±5.8IU/L14.7±8.6 IU/L↑LH: 2 194 1.03↑FSH: 0 194 0NRNR5–20IU/L-10 Baseline serum levels: T = total testosterone; Pr = prolactin; LH = luteinizing hormone; FSH = follicle-stimulating hormoneSD = standard deviation; n = number of events; N = total number of participants; % = prevalenceAssay: chemiluminescent microparticle immunoassay (CMI); electrochemiluminescence immunoassay (ECLA), radioimunoassay (RIA)* All patients in those studies were diagnosed with ED and hypogonadism at baseline; ‡ secondary hypogonadism caused by hypothalamic-pituitary structural abnormalities; ¥ approximately 2/3of men on this study were using testosterone gel
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This report is based on research co
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This document is in the public doma
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AcknowledgmentsThe authors would li
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ContentsExecutive Summary..........
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Table 17: Intra-urethral Treatment:
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Figure 63. Absolute Mean Change Fro
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associated with ED treatments. Two
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ED as a main complaint. In only one
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different formulations/modes of app
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Evidence Report
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flaccidity are no less important th
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prostatectomy, antipsychotic agents
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disease). Furthermore, there is ins
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Analytic FrameworkFigure 1. Analyti
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KQ 3. Harms of pharmaceutical treat
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Figure 2. Modified QUOROM Flow Char
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that included intervention characte
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Prevalence of Hypogonadism (Total S
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stimulation and a challenge test wi
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Overview of Trials79-84,86-88,90,91
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131,137,138,142,143,147,151,155,156
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pectoris occurred in a participant
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statistical test results for the ob
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individual Q1-Q15 items, 104,106,15
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Proportion of participants with hea
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erectile maintenance frequency, IIE
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Oral Treatments — Phosphodiestera
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Patients were instructed to take th
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Results obtained from two trials 19
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improved erections was higher in pa
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Clinically homogenous groups of pat
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Oral Treatments — Phosphodiestera
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The approximate proportion of smoke
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value was not reported). Even thoug
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Tadalafil (20 mg) versus tadalafil
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scheduled dosing regimen (90 percen
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Proportion of patients with improve
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Sublingual Treatments - Apomorphine
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been taking over the past two or fo
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apomorphine (5 and 6 mg: 38 and 49
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heterogeneity with respect to popul
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Finally, two studies reported on wh
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the second study, prolonged erectio
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Moxisylate versus placebo. One tria
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Quantitative SynthesisThere was a l
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erection” versus one placebo trea
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methods of allocation concealment.
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Prazosin (IU) versus placebo. One t
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reported adequate allocation concea
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Hormonal Treatments Literature Sear
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Harms. In the first trial, the diff
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sex with partner (scale 1-6, with =
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Page 109 and 110: (MEDQoL) score (range 0-100) compar
Page 111 and 112: group (16.7, 12.5, and 8.3 percent,
Page 113 and 114: Question 3a. What Are the harms of
Page 115 and 116: Chapter 4. DiscussionThis evidence
Page 117 and 118: Question 1: What is the Clinical Ut
Page 119 and 120: Questions 2-3: What are the Benefit
Page 121 and 122: Harms. There were no obvious differ
Page 123 and 124: alone. Compared with trimix alone,
Page 125 and 126: PhentolamineEfficacy. The results i
Page 127 and 128: Question 2a-b: Do Specific Patient
Page 129 and 130: Methodological and Logistic Limitat
Page 131: Tables and Figures.Summary TablesTa
Page 135: 123Study details 1 Study Design Set
Page 139: 125Table 2: Prevalence of Hypogonad
Page 143: 127Study Details 2 Study Design Set
Page 147: 129Table 4: Prevalence of Hypogonad
Page 151: 131Study Details 5 Study Design Set
Page 155: Table 7: Prevalence of Hyperprolact
Page 161: 136Study details 10 Study design Se
Page 164 and 165: Author yearCappelleri (2000)Albuque
Page 166 and 167: Table 12: Intracavernosal Injection
Page 168 and 169: Treatment Control Relative RiskStud
Page 170 and 171: StudyED etiologyTreatmentGroup% (n/
Page 172 and 173: StudyAdverse EventsPgE 1 vs. Papave
Page 174 and 175: StudyAdverse EventsTrimix vs. Trimi
Page 176 and 177: StudyAdverse EventsTreatmentGroup%
Page 178 and 179: StudyRosen 2004AE > 5% inboth treat
Page 180 and 181: Study ED Etiology OutcomeTreatmentG
Page 182 and 183: StudyPeterson 1998Adverse EventTrea
Page 184 and 185: Table 20: Alprostadil (Topical Crea
Page 186 and 187: Table 22: Topical Treatment: Patien
Page 188 and 189: Table 23:Testosterone: Improvement
Page 190 and 191: Study/patient CharacteristicsCavall
Page 192 and 193: Table 25: Testosterone Treatment: I
Page 194 and 195: Study/patientCharacteristicsOutcome
Page 196 and 197: Study/patientCharacteristicsShabsig
Page 198 and 199: study withdrawalDihydrotestosterone
Page 200 and 201: Testosterone 1% Gel + Sildenafil 10
Page 203: 176Author (year)CountrySpeel (2005)
Page 207: 178Pomeranz(2002)Pomeranz(2005)Sinh
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StudyStudyDesignPatientsTreatment(s
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Figures Note: Figure 1 (Analytic Fr
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Figure 9. Headache (all cause)Figur
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Figure 13. Improved erection (GEQ-Q
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Figure 1. The mean IIEF-Q3 score: m
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Figure 26. Any adverse event (all c
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Figure 34. Improved erection (GEQ-Q
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Figure 40. Successful intercourse a
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Figure 46. Serious adverse eventsFi
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Figure 52. The mean IIEF “EF doma
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Figure 58. Flushing (all cause)Figu
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Figure 64. Mean per-patient percent
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Figure 70. Improved erection (GAQ-Q
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References and Included Studies 1.
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52. Deeks JJ, Higgins JP, Altman DG
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treatment withdrawal. Int J Impot R
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133. Olsson AM, Persson CA, Swedish
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May-Jun;27(3):480]. J Androl 2006Ma
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209. Hellstrom WJ, Elhilali M, Home
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study in 14 European countries. J S
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prostaglandin E1. J Urol 1992 Oct;1
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327.and mood in men with erectile d
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371. Shmueli J, Israilov S, Segenre
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List of Acronyms/AbbreviationsCLINI
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IU/Lkgkg/m2mmgmg/dmLmmol/LNng/dLng/
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Appendix A. Search StrategiesMedlin
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22. erecti$.tw.23. 21 or 2224. CLIN
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14. 3 and 1315. limit 14 to yr="199
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1. exp Sleep Apnea Syndromes/2. Opt
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Appendix B. Data Assessment, Data A
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Cross-national ecological analysisO
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Randomized Controlled Trials (Jadad
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Appendix C. Evidence TablesC1-Oral
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AuthorFundingN; study design; eligi
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C-11 AuthorFundingN; study design;
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C-83 C2-Oral Vardenafil AuthorFundi
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C-105 C3-Oral Tadalafil AuthorFundi
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C-135 F4-Apomorphine (sublingual) A
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C-191 C6-Subcutaneous Treatment Tri
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C-195 C7- Intra-urethral Suppositor
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C-237 C10-Off Label Treatments Auth
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References(1) Abdel-Naser MB, Imam
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in Colombia, Ecuador, and Venezuela
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(67) Rendell MS, Rajfer J, Wicker P
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(100) Martin-Morales A, Meijide F,
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controlled study. Urology 2006; 68(
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(166) el-Saleh JC, Keogh EJ, Chew K
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(201) Wessells H, Levine N, Hadley
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with hypogonadal symptoms. Arch Gen
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Appendix D. Reference List of Exclu
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Akduman B, Crawford E D. The PCPT:
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Anderson R U, Wise D, Sawyer T et a
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Atala A, Amin M. Current concepts i
Page 811 and 812:
Barbaree H E, Mewhort D J. The effe
Page 813 and 814:
Bereczky Z, Bolus M, Chetty P et al
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Blaya C, Seganfredo A C, Dornelles
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Brioni J D, Moreland R B, Cowart M
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Campbell S F. Science, art and drug
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Champion H C. Erectile dysfunction
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Chung W S, Choi H K. Erotic erectio
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Crasilneck Harold B. Hypnotic techn
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De Leval J, Boca P, Youssef E et al
Page 829 and 830:
Doggrell S A. Combination of finast
Page 831 and 832:
Eardley I. Optimisation of PDE5 Inh
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Evans M F. Critical appraisal: Lose
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Formenti S C, Lieskovsky G, Simonea
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Garcia-Campayo Javier, Sanz-Carrill
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Gleave M, Qian J, Andreou C et al.
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Carson C C. Erectile dysfunction: E
Page 843 and 844:
Glina S. Testosterone and erectile
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Kalsi J S, Bahadur G, Muneer A et a
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McMahon C G. New treatment options
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Padma-Nathan H. Efficacy and tolera
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Shabsigh R, Rajfer J, Aversa A et a
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Wincze John P, Carey Michael P. Sex
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Tan R S. Novel treatment options fo
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Gupta A, Cohen B H, Ruggieri P et a
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Anonymous. Sildenafil appears safe
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Bella A J, Brock G B. Tadalafil: A
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Carson C C, Burnett A L, Levine L A
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Curran M, Keating G. Tadalafil.[err
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Fagan T C, Buttler S, Marbury T et
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Greenstein A, Plymate S R, Katz P G
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Hunter R H, Joy C B, Kennedy E et a
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Kloner R A, Mitchell M, Emmick J T.
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Long R L, Sherman L S, Lombardi T J
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Miller N, Smolkin M E, Bissonette E
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Nurnberg H, George. Erectile Dysfun
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Porst H, Giuliano F, Glina S et al.
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Salonia Andrea, Briganti Alberto, M
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Solursh Lionel P, Solursh Diane S.
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van Basten J P, Van Driel M F, Hoek
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Yasumoto R, Nishisaka N, Sakakura T
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Chen J, Godschalk M F, Katz P G et
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Hellstrom W J. Vardenafil: a new ap
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Webb D J, Muirhead G J, Wulff M et
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Kim J M, Joh Y D, Huh J D et al. Do
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Tariq S H, Haleem U, Omran M L et a
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Aizenberg Dov, Gur Shay, Zemishlany
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Beretta G, Marzotto M, Zanollo A et
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Cheng E. Real-life safety and effic
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English J C, King D H C, Foley J P.
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Goldstein I, Auerbach S, Padma-Nath
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Jackson G. Sildenafil (Viagra): New
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Lane B Z, Ausmundson S J, Butler R
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McMahon C G. An attempt to standard
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Mulhall J P, Land S, Parker M et al
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Pohanka M, Kanovsky P, Bares M et a
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Ruof J, Graf-Morgenstern M, Mnller
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Sparwasser C, Treiber U, Bahren W e
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Wagner G, Montorsi F, Auerbach S et
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Anderson R A, Martin C W, Kung A W
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Baggaley M R, Hirst J F, Watson J P
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Buvat J, Boujadoue G. Testosterone
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Contreras L N, Masini A M, Danna M
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Engelhardt P F, Daha L K, Zils T et
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Glasser S P. Safety of PDE 5 inhibi
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Holtkamp M, Weissinger F, Meierkord
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Kirby R S. Report from London. Pros
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Lexchin J. New drugs with novel the
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Mealy N E. Avanafil. Drugs of the F
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Nakata M, Takashima S, Kaminou T et
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Phillips B G, Kato M, Pesek C A et
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Saad F, Grahl A S, Aversa A et al.
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Sipski M, Alexander C, Guo X et al.
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Traish A M, Goldstein I, Kim N N. T
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Wilt T J, Fink H A. Is antidepressa
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Price D E, Cooksey G, Jehu D et al.
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Bolona E R, Uraga M V, Haddad R M e
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Anonymous. Sublingual apomorphine:
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Bouloux P. Testim 1% testosterone g
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Christ B, Brockmeier D, Hauck E W e
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Fein R L. Classification of sexual
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Green B G, Martin S. Clinical asses
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John H, Lehmann K, Hauri D. Intraur
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Lee W R. The role of androgen depri
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Mealy N E. Alprostadil cream. Drugs
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Murphy J C, Srinivas S, Terris M K.
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Pommerville P. Drug treatments for
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Saie D J, Sills E S. Hyperprolactin
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Steidle C P, McCullough A R, Kamine
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Weiss J N, Badlani G H, Ravalli R e
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Anonymous. Study shows patients tak
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Bartlik Barbara D, Kaplan Peter, Ka
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Cawello W, Schweer H, Dietrich B et
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Del Popolo G, Li Marzi V, Mondaini
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Gallo L, Perdona S, Autorino R et a
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Hofner K, Claes H, De Reijke T M et
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Kloner R A, Hutter A M, Emmick J T
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Maan Z, Arya M, Shergill I et al. P
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Montorsi F, Strambi L F, Guazzoni G
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Phelps J S, Jain A, Monga M. The Ps
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Sato Y, Suzuki N, Adachi H et al. E
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Strachan M W, Teoh W L, Don-Wauchop
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Weinhardt L S, Carey M P. Prevalenc
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Appendix E. Additional Acknowledgme
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Appendix F. Quality AssessmentRando
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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Jadad Q-1AuthorYearJadad Q-2 Jadad
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Quality Assessment of Observational
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Appendix G. Funnel PlotsSildenafilF
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Figure G-3. Sildenafil (any dose) v
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VardenafilAny dose vs. PlaceboFigur
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Figure G-11. Vardenafil (any dose)
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Figure G-13. Tadalafil (20 mg) vs.
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20 mg vs. 10 mgFigure G-15. Tadalaf
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Appendix H. Instruments Used in the
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1 = Very dissatisfied2 = Moderately
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Appendix I. List of Unobtained Arti
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