Investigational Product Record since last visit
Item
Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
boolean
RSL Rating Scale
Item
INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
boolean
Weight
Item
Weight (without shoes)
float
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic
integer
Sitting Blood pressure diastolic
Item
Sitting Blood pressure (after 5 minutes sitting) diastolic
integer
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
Adverse Experiences
Item
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the Week 8 Visit?" in the Adverse Experience section at the back of this book.
boolean
Date of blood sample
Item
Date of blood sample
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
Yes -> If "Positive", please record details in the Pregnancy Information section on the Study Conclusion page at the back of this book. (2)
Item
Is the patient a female of childbearing potential?
text
Code List
Is the patient a female of childbearing potential?
CL Item
Yes -> If "Yes", please perform a pregnancy dipstick test and record results below. (2)
Item
Results pregnancy dipstick
text
Code List
Results pregnancy dipstick
CL Item
Positive -> If "Posititve", please record details in the Pregnancy Information section on the Study Conclusion page at the end of this book. (2)
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