Table 2.

Data management, calendar

	Screening and inclusion	Treatment	Follow-up
			7d	30d	2 m	3 m	4 m	5 m	6 m	7 m	8 m	9 m	10 m	11 m	12 m
Items
Eligibility screen	X
Informed consent	X
Randomization	X
Demographic data	X
Clinical evaluation	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Treatment procedure		X
End-of-study evaluation															X
Type of appointment
Face-to-face visit	X	X		X					X						X
Telephone			X		X	X	X	X		X	X	X	X	X
Assessments
Quality of life	X								X						X
AEs		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Obstructive symptoms	X		X	X	X	X	X	X	X	X	X	X	X	X	X
Blood test	X			X					X						X
MRE	X
Endoscopy	X								X
Tobacco smoking	X		X	X	X	X	X	X	X	X	X	X	X	X	X
Medication	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X