Original Primary Outcome: Same as current

Current Secondary Outcome:

• Time to first HES flare [ Time Frame: Up to 33 Weeks ]
  The time to first HES flare will be calculated from the date of randomization and the start date of the HES flare.
• Proportion of subjects who experience an HES flare during Week 20 through Week 32 [ Time Frame: From Week 20 until Week 32 ]
  An HES flare during Week 20 through Week 32 will be defined as an HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit.
• Number of HES flares per subject per year [ Time Frame: Baseline (randomization) and up to 33 Weeks ]
  The rate of HES flares will be calculated for each subject as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or otherwise the study withdrawal date. Start date of an HES flare must be at least 14 days apart from the resolution date of the preceding HES flare to be considered as a separate episode of HES flare.
• Change from baseline in fatigue severity based on Brief Fatigue Inventory (BFI) item 3 (worst level of fatigue during past 24 hours) at Week 32 [ Time Frame: Baseline and up to Week 32 ]
  BFI item 3 assesses the worst level of fatigue during past 24 hours using a numeric rating scale anchored with 0 (no fatigue/interference) and 10 (as bad as you can imagine/completely interferes).

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: July 14, 2016
Date Started: March 7, 2017
Date Completion: February 25, 2019
Last Updated: May 15, 2017
Last Verified: May 2017