TABLE 1.

Summary of Patient Accountability

FPSCGTotal
Total population screened668
ITT population471154625
Withdrawal after randomization, n (%)90 (19)32 (21)122 (20)
 Adverse event*2 (<1%)2 (1%)4 (<1%)
 Consent withdrawn9 (2%)1 (<1%)10 (2%)
 Lack of efficacy03 (2%)3 (<1%)
 Lost to follow-up3 (<1%)1 (<1%)4 (<1%)
 Nonadherence2 (<1%)1 (<1%)3 (<1%)
 Protocol violation72 (15%)21 (14%)93 (15%)
 Other2 (<1%)3 (2%)5 (<1%)
Completed (n [%])381 (81%)122 (79%)503 (80%)
  • ITT indicates intention to treat.

  • * Includes related to lack of efficacy and not related to lack of efficacy.

  • Adverse event related to lack of efficacy for both patients.