Two subjects discontinued because of adverse events (AEs): one for increased transaminases related to study drugs and one for unrelated premature delivery (premature delivery led to an inability to fulfill protocol requirements as the patient missed the postpartum visit).
In the ROCKET AF study "per-protocol" "on-treatment," only subjects who fulfilled the protocol in terms of the eligibility, interventions, and outcome assessment were analyzed.
Out of a total of 110 patients screened for acromegaly, 98 fulfilled the protocol inclusion criteria and were started on octreotide LAR after their informed consent had been obtained.
Following written informed consent from the subject or legal representative, patients with severe sepsis or septic shock [ 15] and AKI who fulfilled the protocol selection criteria (Table 1) were randomized in a double-blind, placebo-controlled design.
The total cost of the intervention if the practice nurses and lay educators had fulfilled the protocol and given all patients two consultations and 4 telephone consultations (Scenario 1) would have increased the costs to £241 for practice nurses and £186 for lay educators but still with no significant differences between the study arms (£54).
All patients included in this study had been enrolled in National Institutes of Health NIH ARDS Networkrk studies and had received low tidal volume ventilation in accordance with previously published protocols and fulfilled all NIH ARDS Network protocol inclusion and exclusion criteria [ 21].
At the completion of the study (week 104), 26 (36.1%) of the 72 subjects attending this visit were retreated following confirmation that they fulfilled the protocol-defined criteria.
Between Month 9 and 12, 34.5% of the subjects attending this visit were retreated following confirmation that they fulfilled the protocol-defined criteria (average amount, 0.5 mL per side).
To this end, after one or two treatment sessions over the initial 4-week period of the study, further treatment to the midface with the study product (or any other aesthetic treatment) was not permitted prior to the week 78 visit and only in those subjects who fulfilled the protocol-defined criteria for retreatment at this visit.
The ePP population included all randomised patients fulfilling the protocol eligibility criteria, having taken at least 80% of the study medication when not previously classified as early treatment failures, completing the day 28 assessment and having an evaluable PCR in case of recurrent parasitaemia.
