Summary chart of visits (control group)
| Procedures control group | Visit 1 (first 30 days) | Visit 2 to Visit 7 (month +1 to+6) | Visit 8 to Visit 13 (month +7 to +12) | Visit 14 and Visit 15 (month +15 and +18) |
| Informed consent | X | |||
| Inclusion/exclusion criteria | X | |||
| Randomisation | X | |||
| Medical history/anamnesis | X | X | X | X |
| Physical examination* | X | X | X | X |
| Pregnancy test | X | |||
| Antiviral prophylaxis | X | X | ||
| CMV PCR sample† | X | X | ||
| Haemogram/biochemistry‡ | X | X | X | X |
| Adverse events/concomitant medication | X | X | X | X |
*Physical examination: weight, heart rate, blood pressure, temperature, abdominal palpation and presence of oedemas
†CMV PCR will be compulsory when antiviral prophylaxis is discontinued. The first CMV PCR will be performed at Visit 7 (month +6), coinciding with the discontinuation of antiviral prophylaxis. At Visits 14 and 15 it will not be compulsory to draw samples for viral load (unless indicated according to the center’s clinical practice).
‡Haemogram: red blood cells, haemoglobin, leukocytes, neutrophils and platelets. Biochemistry: alkaline phosphatase, gamma-glutamyltransferase, alanine aminotransferase, aspartate aminotransferase, C-reactive protein, bilirubin, albumin and creatinine.
CMV, cytomegalovirus; PCR, polymerase chain reaction.