Table 1.

Chronology submission and revisions PPROMEXIL Follow-up study

Version no.	Date (DD-MM-YYYY)	Main reasons for change
1	29-09-2016	N/A, first submission to MEC
2	20-12-2017	MEC2016_217#C20161752 Modifications requested by MEC d.d. 05-09-2016
3	04-01-2018	Modifications requested by MEC d.d. 04-01-2018 Additional information on informed consent about saving data (mother and child) up to 15 years after trial
3	10-01-2018	Approval MEC d.d. 10-01-2018
4	31-05-2018	Amendment 1: Administrative modifications. Change of acronym to PPROMEXIL Follow-up. Addition of two questionnaires (ISAAC and Puberty Developmental Scale).
4	04-07-2018	Approval amendment version 4 d.d. 04-07-2018
5	10-08-2018	Amendment 2: Modification in protocol on how to recruit participants (via research nurses and PhD student). Modification in Patient Information Files on recruitment.
5	23-08-2018	Approval amendment version 5 d.d. 23-08-2018
6	06-11-2018	Amendment 3: Clarification on informed consent procedure, parents and participants will be counselled through the telephone and sign informed consent at home. Minor modifications in the General Health Questionnaire.
6	23-11-2018	Approval amendment version 6 d.d. 23-11-2018
7	03-04-2019	Amendment 4: Addition of patient information files for children age 12–15.
7	12-04-2019	Approval amendment version 7 d.d. 12-04-2019

ISAAC, International Study of Asthma and Allergies in Childhood questionnaire.