Table 1.

Participant timeline

D day, IP investigational product

*Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days (168 h) prior to their baseline and screening visit (D0) or agree to use adequate methods of contraception for the duration of drug administration

**Blood test for sirolimus levels—collect a 4 ml EDTA tube (purple tube) and record the time the cream was last applied (e.g. 10 pm and date)

^aSites are requested to indicate any out-of-range results of biochemistry and haematology tests performed as part of standard-of-care up to and including 3 months prior to the baseline visit and upload de-identified results into the study database

^bSites are requested to indicate any out-of-range results of biochemistry and haematology tests performed as part of standard-of-care up to and including 14 days prior to the visit and up to and including 7 days after the visit and upload de-identified results into the study database