The changes to the CTP included clarifications and corrections to the schedule of assessments, the frequency of Thyroid-stimulating hormone (TSH) testing, the creatinine clearance measurement formula, and procedures to be followed in case of pregnancy in a trial patient or their partner.

The following main changes, clarifications, and corrections of inconsistencies were implemented: . Patients who completed trial 1199-0340 (approximately 14 patients) were added to the pool of patients who could enter the present trial . Selexipag was added to the list of oral or parenteral therapies for pulmonary hypertension; patients treated for pulmonary hypertension were highly recommended to discontinue nintedanib in Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS-ON) . Clarification of the collected blood volume for safety laboratory tests (110 (milliliter) mL in the first year and 45 mL during any subsequent year) . An inconsistency in the list of procedures to be done at dose-modification visits was corrected to include safety laboratory testing . The length of the Residual Effect Period (REP) was corrected from 28 days to 7 days, based on the half-life of nintedanib

The following changes, clarifications, and corrections of inconsistencies were implemented: . The introduction was updated to ensure it reflected current knowledge and recent data on the medical background relevant to this trial . The benefit-risk assessment was updated to reflect new information on the Covid-19 pandemic . The duration of the trial design was clarified, the end of the trial was more precisely described, and it was documented that the trial could last beyond availability of marketed drug . The numbers of wallets provided at Visits 5 and 6 were corrected . The recommendations for cases of hepatic injury were changed: o The wording regarding withdrawal and interruption of trial medication was revised for clarification. It was also noted that trial medication could be resumed if clear evidence of an alternative cause for hepatic injury was identified. It was specified that this was only possible after consultation with the sponsor and if prior to restart, liver laboratory values were normal. Liver laboratory values had to be monitored weekly for the first 4 weeks after reintroduction and every 2 weeks for the following 8 weeks. . Following the first wave of the Covid-19 pandemic, the visit schedule was modified for exceptional circumstance (such as a pandemic) to allow flexibility in visit conduct to ensure patients safety by ensuring continuous treatment.