Author: Arabi, Yaseen M.; Asiri, Ayed Y.; Assiri, Abdullah M.; Aziz Jokhdar, Hani A.; Alothman, Adel; Balkhy, Hanan H.; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M.; Memish, Ziad A.; Ghazal, Sameeh; Al Faraj, Sarah; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Al Mekhlafi, Ghaleb A.; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Almotairi, Abdullah; Al Bshabshe, Ali; Kharaba, Ayman; Jose, Jesna; Al Harthy, Abdulrahman; Al Sulaiman, Mohammed; Mady, Ahmed; Fowler, Robert A.; Hayden, Frederick G.; Al-Dawood, Abdulaziz; Abdelzaher, Mohamed; Bajhmom, Wail; Hussein, Mohamed A.
Title: Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-ß1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial Document date: 2020_1_3
ID: 0cah15lg_39
Snippet: where n ki is the sample size per group for the i th twostage design of the k th stage. In the interim analysis (i.e., at each i = 1 of the k th two-stage), the primary outcome will be evaluated, and the trial sample size will be reestimated for the subsequent stage based on the observed effect size using the following formula assuming a conditional power of 80% (Pc = 0.8) to decide if the trial should continue:.....
Document: where n ki is the sample size per group for the i th twostage design of the k th stage. In the interim analysis (i.e., at each i = 1 of the k th two-stage), the primary outcome will be evaluated, and the trial sample size will be reestimated for the subsequent stage based on the observed effect size using the following formula assuming a conditional power of 80% (Pc = 0.8) to decide if the trial should continue:
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