Table 4.

Assessment schedule

Period	Period 1						Period 2
Visit	1	2	3	4	5	6	7	8	9	10
Week/month	Pre-LTx	LTx	W1	W4	M3	M6	M9	M12	M24	M36
Informed consent	x
Inclusion/exclusion	x	x
Randomization		x
Demography	x
General medical history	x
Transplantation information		x
Background donor		x
Protocol biopsy				x	x			x
HLA typing	x
HLAab/DSA (stored)	x		x	x	x			x	x	x
Vital signs	x	x	x	x	x	x	x	x	x	x
Lung function test Spiro, DLCO, VOL	x			x	x	x	x	x	x	x
6 min walk test	x							x	x	x
Quality of life	x							x	x	x
Laboratory test
Hematology/biochemistry	x	x	x	x	x	x	x	x	x	x
Lipid profile	x					x		x	x	x
Viral serology and PCR	x			x	x	x	x	x	x	x
Flow cytometry (T cell activation) & ImmunKnow® assay				x	x	x	x	x
Pregnancy test		x
Urinalysis	x		x	x		x		x	x	x
cGFR	x		x	x	x			x	x	x
mGFR	x				x			x	x	x
HR-CT scan	x		x		x			x	x	x
Drug concentration
Cya/Tac blood conc level			x	x	x	x	x	x	x	x
MPA blood conc level				x	x
Echocardiography in PAH	x			x	x			x	x	x
DNA/RNA isolation		X	x	x	x	x		x
Tac pharmacokinetics				x	x
OGTT	x					x		x	x	x
SORT analysis	x		x	x	x	x	x	x	x	x
Weight-to-height ratio		x		x	x	x	x	x	x	x
Cytokines and inflammatory variables	x		x	x	x	x		x

LTx lung transplantation, W week, HLA human leucocyte antigen, ab antibody, DSA donor-specific antibodies, DLCO diffusing capacity of the lung for carbon monoxide, VOL lung volumes, PCR polymerase chain reaction, cGFR calculated glomerular filtration rate, mGFR measured GFR, HR-CT high resolution computer tomography, Cya cyclosporine, Tac tacrolimus, PAH pulmonary arterial hypertension, DNA deoxyribonucleic acid, RNA ribonucleic acid, OGTT oral glucose tolerance test