Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

Primary outcomes

1. Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)

   Time frame: 4 Years

   An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.

2. Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale

   Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)

   Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.

3. Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale

   Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)

   The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.

4. Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale

   Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)

   The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.