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Journal of Patient-Reported Outcomes

Table 1 Study schemaa and evaluable modified intent-to-treat population

From: Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm

 

Visit 1 (screening, Week 0)

Visit 2 (end of no-drug qualification period, Week 4)

Visit 5 (end of single-blind placebo treatment period, Week 10)

Visit 12 (end of double-blind treatment period, Week 23)

Evaluable mITT

N = 325

N = 324

N = 238

N = 229

FSDS-DAO

X

X

X

X

FSFI

X

X

X

X

GAQ

  

X

X

WITS-9

  

X

X

  1. FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm; FSFI = Female Sexual Function Index; GAQ = General Assessment Questionnaire; mITT = modified intent-to-treat; WITS-9 = Women’s Inventory of Treatment Satisfaction
  2. aThe FSEP-R was completed after each sexual encounter
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