Sentence examples for major protocol violation from inspiring English sources

An additional per-protocol analysis (PP) was carried out for participants without major protocol violation who could be assessed at the end of 3rd treatment.

A total of 230 patients entered the BZD withdrawal phase and were taken into account for the ITT analyses, 136 patients allocated to lithium and 94 to placebo, of whom 32 presented a major protocol violation.

The intention-to-treat population consisted of 114 patients, while the per-protocol population included 63 patients: 51 patients were considered major protocol violation (13 patients treated less than 3 attacks and 38 made wrong use of rescue medication) (Fig. 1).

Withdrawal criteria were withdrawal of consent, appearance of other species of Plasmodium or major protocol violation.

Compliance < 70% was considered a major protocol violation.

Six COBRA patients and two COBRA-light patients had a major protocol violation (table 3).

There were a total of 96 major protocol violations.

Serious adverse events and major protocol violations were reported to DRRC, ANSM and CPP.

The PPS includes all patients who completed the study with no major protocol violations.

Twenty patients were excluded from PPS due to major protocol violations resulting in 105 patients within the PPS (Table 3).

The "per protocol" (PP) population (patients of the ITT population with no major protocol violations) was used to perform confirmatory analyses on the primary endpoint.