Table 1.

Overall Schedule of Enrolment, Interventions, and Assessment, in Accordance with the SPIRIT Statement

TIMEPOINT	Enrolment		Allocation	Post-Allocation									Close-Out
	-t1 (−28 to −7 d)	-t2 (−7 to −1 d)	0	t1 (3 m)	t2 (6 m)	t3 (9 m)	…	t12 (36 m)	t13 (42 m)	t14 (48 m)	t15 (54 m)	…	t19 (72 m)
ENROLMENT:	X
Informed consent	X
Demographic features	X
Medical history	X
Allocation			X
INTERVENTIONS:
Icotinib group				X	X	X	X	X
Placebo group				Y	Y	Y	Y	Y
ASSESSMENTS:
Vital signs		X		X	X	X	X	X
EGFR gene test	X
Tumour tissue sample collection	X
Performance status		X		X	X	X	X	X
Complete blood count		X		X	X	X	X	X
Blood biochemistry		X		X	X	X	X	X
Carcinoembryonic antigen		X		X	X	X	X	X
Blood Biomarkers	X			X	X	X	X	X	X	X	X	X	X
Urine analysis		X
ECG (potentially left ventricular ejection fraction)		X
Health-related quality of life		X		X	X	X	X	X
Pregnancy test		X
Radiographic assessment	X			X	X	X	X	X	X	X	X	X	X
Adverse event				X	X	X	X	X	X	X	X	X	X
Anti-tumour therapy									X	X	X	X	X