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Table 3 Comparison of C601/C602 to PATH for PWS Change from Baseline at 26, and 52 Weeks

From: Behavioral changes in patients with Prader-Willi syndrome receiving diazoxide choline extended-release tablets compared to the PATH for PWS natural history study

Parameter

 

C601/C602

PATH for PWS

 

HQ-CT

Measured at

n

LSmean [SE]

n

LSmean [SE]

p-value

Propensity quintiles

26 weeks

108

-8.3 [0.75]

195

-2.5 [0.43]

< 0.001

Worst-Case Sensitivity analysis

26 weeks

123

-5.4 [0.97]

229

-2.5 [0.39]

0.006

Worst-Case Sensitivity analysis

52 weeks

123

-5.9 [1.04]

197

-3.1 [0.43]

0.015

PWSP domain

Measured at

n

LSmean [SE]

n

LSmean [SE]

p-value

Aggressive Behavior

52 weeks

103

-2.1 [0.31]

147

0.3 [0.26]

< 0.001

Anxiety

52 weeks

103

-3.2 [0.35]

147

0.1 [0.30]

< 0.001

Compulsivity

52 weeks

103

-3.0 [0.30]

147

-0.2 [0.25]

< 0.001

Depression

52 weeks

103

-1.0 [0.18]

147

-0.1 [0.15]

0.003

Disordered Thinking

52 weeks

103

-1.4 [0.20]

147

0.01 [0.17]

< 0.001

Rigidity/

Irritability

52 weeks

103

-3.1 [0.36]

147

-0.2 [0.30]

< 0.001