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Table 2 Study schedule for observation, inspection, and evaluation

From: Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial

  1. ● Represents the examination and assessment items to be performed at each visit
  2. #1: Acceptable range of the required tests at Day 1, as indicated by 〇, are 14 days. Treatment using test device starts at Day 1
  3. #2: Consent from the participants must be obtained at least 28 days before the start of the study
  4. #3: Participants recall and assess the level of pain experienced over the past 4 weeks at each visit
  5. #4: Data collected through the electronic Patient Reported Outcome (ePRO) system will be used for the assessment
  6. #5: The participant diary will start recording from the date of consent. Recordings until the day before Day1 will be on paper diary, while from Day1 onwards, record will be collected by ePRO
  7. BMI: body mass index; NRS: Numeric rating Scale; B&B: Biberoglu and Behrman; EHP-30: Endometriosis Health Profile-30; EQ-5D: EuroQol 5-Dimension
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Reproductive Health

ISSN: 1742-4755