Adverse events were reviewed during the first 4 days of cycle 1, then every week from weeks 2 to 7 and then every 3 weeks from week 7 onwards, and at withdrawal.
Floating embryoid bodies (EBs) were cultivated for 3 weeks from each iPS cell set, and then spontaneously differentiated onto gelatin coated dishes for 12 days.
The mdx mouse model of DMD shows staged histopathology, with little evidence of dystrophy from 0 to 3 weeks of age, then wide-spread necrosis from 3 to 6 weeks, followed by successful regeneration and a milder, more stable histological picture.
These changes take effect 20 weeks from now, and until then, "Nightline" remains in its existing time slot with a lot of important work to do, including covering two conventions, four debates and a presidential election.
Prednisolone was gradually tapered from 3 weeks and then stopped between 3 and 6 months.
For the following 3 weeks participants then choose from sessions on i) diet, sleep, exercise, home and work life; ii) thoughts and feelings; iii) talking to others.
The scheduled regimen was administration at week 0, 2, and 4 (induction phase) and then every 4 weeks from week 6 (maintenance phase), although the WELCOME study is exploring the efficacy of a more frequent (every 2 weeks) maintenance regimen.
All patients had a pretreatment tumor assessment by computerized tomography (CT) scan, which was repeated to assess tumor response after a maximum of 8 weeks from the beginning of the treatment, then every 2 months until 9th month, and every 4 months thereafter.
Prednisolone was gradually tapered from 3 weeks onwards and then stopped between 3 and 6 months, according to each centre's practice.
The remaining mice (all groups) drank water for another 8 weeks (i.e.: 16 weeks from beginning of the study) and were then euthanized (Washout: W16, C16, L16).
Technical support and guidance were provided 24 hours a day, 7 days a week for 2 weeks from the hospital's information technology specialists, then as needed.
