Table 2.

Schedule of assessments and procedures.

Activities	Screening		Dosing phase					Follow-up
Empty Cell	Screening (Visit 1)	Baseline (Visit 2)	Optional blood draw	Visit 3	Visit 4	Visit 5	Visit 6	Visits 7–9
Empty Cell	Day −14a,b	Day 0	Day 7–21	Day 28a	Day 56a	Day 84a	Day 112a	Empty Cell
Empty Cell	Empty Cell	Week 1	Week 1 - Week 3	Week 4	Week 8	Week 12	Week 16	Weeks 20, 24, 28a
Informed consent/assent	X
Demographics	X
Inclusion/exclusion criteria	X	X
Medical history	X
Collection of height/weight	X	X		X	X	X	X
Urine pregnancy testc	X				X		X
Begin run-in periodd	X
Dispense/review diary cards	X	X		X	X	X	X	X
Randomize to dose group		X
Dispense study drug		X		X	X	X
Collect unused study drug				X	X	X	X
Assess adherencee		X		X	X	X	X
Adherence communicationf		X		X	X	X	X	X
Urine calcium/creatinine ratiog	X			X	X	X	X
Inflammatory biomarkersh		X		Xi	Xi	Xi	X	Xi
Serum 25(OH) vitamin D (local laboratory)	X							Xj
Serum 25(OH) vitamin D (central laboratory)k		X	Xl	X	X	X	X	X
Asthma assessments (ACT, c-ACT)	X	X		X	X	X	X
Concomitant medications review	X	X		X	X	X	X	X
Adverse event assessment	X	X		X	X	X	X	X

^aScreening is 14 (±7) days prior to baseline. Except for the optional blood draw and basely, days are ±7.

^bA focused physical examination will only be required if an unplanned study termination visit occurs.

^cFor females of child-bearing potential only; a pregnancy test will also be done if a female participant does not remain in the study through Visit 6.

^dStart of daily diary cards.

^eWeekly adherence will be assessed by diary cards and pill count at visits.

^fPeriodic communication may be via phone, text, or email as participant prefers. Communication will occur at least every other week in weeks without a study visit between Visits 2 and 6, and then contact will be made, minimally, during the week prior to each Follow-up Visit (visits 7, 8 and 9).

^gPerformed locally; if urine Ca++/Cr ratio is >0.37 on repeat testing [after adequate hydration and within 2 business days of initial test], the patient will return for a local serum calcium and 25(OH)D. If urine Ca++/Cr sample is not obtained at the scheduled visit, the sample must be obtained within 2 business days.

^hTNFα, IL-2, IL-6, IL-10, IL-17 and leptin will be obtained by venipuncture at baseline and Visit 6. If blood for vitamin D level is drawn by venipuncture (vs fingerstick) at other times, sufficient blood will be collected for inflammatory marker determination.

ⁱFor participants having venipuncture (vs fingerstick) blood draw.

^jLocal laboratory determination of serum 25(OH)D will be performed at week 28 (Visit 9).

^kBlood for central laboratory vitamin D determination can be collected by venipuncture or by fingerstick using a microtainer collection tube.

^lAn optional blood draw (fingerstick or venipuncture) can occur any time between week 1 and 3 (from day 7 to day 21, inclusive).