Table 1

Overview of study visits. All assessments at week 0 are part of standard of care

Visit0R123456789RelapseEoS
Week04812162028364452104
Informed consentX
Entry criteriaXX
Medical historyXX
Physical examinationXXXXXXXXXXXX
Laboratory examinationXXXXXXXXXXX(X)
(Serious) adverse eventsXXXXXXX
Prednisolone
Study medication
Quality of lifeXXXXX
Drug dispensingXX
Drug accountabilityXX
  • The colour shades indicate in which period prednisolone and study medication is used.

  • EoS, end of study; R, randomisation; (X), if indicated by treating physician.