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INSTRUCTIONS FOR ARIZONA SEXUAL SIDE EFFECTS FORM ASX, VERSION A (QxQ) I. GENERAL INSTRUCTIONS The Arizona Sexual Side Effects (ASEX) Form will be administered at Visits 2 (baseline), 10 (3 Mo.), 13 (6 Mo.),19 (12 Mo.), 25 (18 Mo.), 31 (24 Mo.) by the clinical rater to assess patient sexual functioning. The five items include: strength of sex drive (Item 1), ease of sexual arousal (Item 2), vaginal lubrication/penile erection (Item 3), ability to reach orgasm (Item 4), and satisfaction with orgasm (Item 5). The ASEX measures the severity of each sexual dysfunction item using a sixpoint Likert-type scale that ranges from 1(little or no impairment) to 6 (complete dysfunction). ASEX total scores range from 5 to 30. Higher ASEX scores reflect greater severity of sexual dysfunction. To mitigate the discomfort of discussing the sensitive topic of sexual functioning, the study will utilize self-administered questionnaire cards that participants read silently to themselves. There are two laminated cards for patient use: 1 blue card for males, and 1 pink card for females. Header Information: The header information consists of key fields which uniquely identify each recorded instance of a form. PATIENT ID NUMBER: Affix the pre-printed label to the form. This is a unique 8-character code assigned at the DCC for each study patient. Labels are provided. FORM CODE: This is a three-letter mnemonic code for the form, which is precoded as “ASX”. VERSION: This is a one-letter version assigned to the form, which is precoded as “A”. VISIT: Visit should be filled in according to which visit it is completed. SEQ #: Fill in the sequence number. It is always 001 PATIENT INITIALS: Enter the first, middle, and last initial of the patient. For those with no middle name, use a ‘‘(dash). For example: A Z VISIT DATE: Enter the date on which the data was collected. Code in numbers using leading zeroes where necessary to fill all boxes. For example, September 6, 2010, would be entered as: 0 9 / 0 6 / 2 0 1 0 M M D D Y Y Y Y ACLAIMS Arizona Sexual Side Effects Form (ASXA) QxQ, 11/2/10 Page 1 of 2 II. DETAILED INSTRUCTIONS FOR EACH ITEM Provide the appropriate self-administered questionnaire card (blue for males/pink for females) and instruct the participant to read the questions silently to themselves. Ask the participant to report only the scale number that corresponds to their experience for each item. A. Instrument Say to the patient: Item 1. “Tell me which number on the scale best reflects your experience for Item 1 during the past week” and record the response. Item 2. “Tell me which number on the scale best reflects your experience for Item 2 during the past week” and record the response. Item 3. “Tell me which number on the scale best reflects your experience for Item 3 during the past week” and record the response. Item 4. “Tell me which number on the scale best reflects your experience for Item 4 during the past week” and record the response. Item 5. “Tell me which number on the scale best reflects your experience for Item 5 during the past week” and record the response. B. Administrative Information Item 6. Comments. This comment field is optional and, if used, should be brief and concise. Item 7. Staff Code: Enter the first, middle and last initial of the person completing this form For those with no middle name, use a ‘-‘ (dash). ACLAIMS Arizona Sexual Side Effects Form (ASXA) QxQ, 11/2/10 Page 2 of 2